Medical Device Newsletter


Aesthetic medical devices' launch, NuEra Tight with FocalRF for personalized body sculpting treatments: Lumenis


The largest energy-based medical device company, Lumenis Ltd., announces the launch of revolutionary NuEra Tight with FocalRF technology, in the Middle East and Europe for body sculp


Non-invasive medical instruments for pain relief in India : OSKA India


OSKA Wellness launched 'OSKA Pulse'; PEMF (Pulsed-Electromagnetic-Field-Therapy) technology-enabled products, in India.

The company is the first enabler of this innovative te


Roche's Cobas 6800/8800 HIV-1/HIV-2 Qualitative Test for HIV/AIDS detection: US FDA approval


US Food and Drug Administration (FDA) approval awarded to Roche for the cobas 6800/8800 HIV-1/HIV-2 Qualitative Test in the US. The healthcare professionals may have a single result


Foundation One Liquid CDx (a comprehensive pan-tumor liquid biopsy test): US FDA approval


Roche received US Food and Drug Administration (FDA) approval for Foundation One Liquid CDx, Foundation Medicine’s comprehensive pan-tumor liquid biopsy test for solid tumor pa


Release of draft guidance on PROs for device manufacturers: FDA


The US Food and Drug Administration (FDA) released a new draft guidance for Device manufacturers for the selection of patient-reported outcome (PROs) instruments in clinical&nbs


Guidelines to conduct COVID-19 screening in TB patients: Health ministry


The Union health ministry releases guidelines stating that tuberculosis (TB) screening will be done for all COVID-19 positive patients and COVID-19 screening will be done for all TB


New workflow and imaging enhancements for Kodex-EPD cardiac mapping and imaging system for heart rhythm disorders: Philips


Royal Philips announces new imaging and workflow enhancements for its novel Kodex-EPD cardiac imaging and mapping system. The system treating a common heart rhythm disorder,&nbs


Launch of High-Flow Oxygen Therapy Device, Noccarc H210 for critical COVID-19 patients: Nocca Robotics


Nocca Robotics Pvt Ltd, of SIIC, IIT Kanpur, launched a clinically validated and certified High- Flow Oxygen Therapy Device for COVID-19 patients. The device is high-quality critical


Abbott Rapid Covid-19 Test Kit For Emergency Use: USFDA Nod


Abbott receives Emergency Use Authorization (EUA) for its BinaxNOW COVID-19 Ag Card rapid test for COVID-19 infection detection from the U.S. Food and Drug Administration (


Ban Lifted on export of PPE medical coveralls & 2/3 ply surgical masks: DGFT


The Directorate General of Foreign Trade (DGFT) lifts ban on PPE medical coveralls and all masks export varieties, except N95 masks.

DGFT, on August 25, 2020, revised the exp


FDA approves Foundation Medicine's pan-tumor biopsy test


The US Food and Drug Administration (FDA) approves Foundation Medicine's pan-tumor liquid
biopsy test FoundationOne Liquid CDx.

The kit's assay uses blood samples to e


India’s first-ever rapid diagnostic test kit for Covid-19 gets ICMR approval


Delhi based Oscar Medicare Pvt. Ltd. that manufactures various in-vitro diagnostic kits have developed a simple, single prick rapid testing kit for detecting COVID


FDA Clearance to Home use Intravaginal Device For Stress Urinary Incontinence (SUI)


The U.S. Food and Drug Administration (FDA) has issued clearance for Flyte™, intravaginal in-home, non-invasive, device meant to strengthen the pelvic floor muscles, which help


High-flow nasal oxygen (HFNO) method seems to be crucial during COVID

HFNO has become synonymous with a bridge between mask and ventilator. It is replacing the invasive mechanical ventilation for treatment of respiratory distre


Leven Medical: India-Dutch collaborative startup announces smart ventilators with AI ML


The smart ventilators can auto adjust patient's oxygen flow. In emergent cases, these send alerts to the concerned medical staff and to family members. The startup claims that the ve


Smart wearable devices may detect COVID-19 even before the symptoms: Fitbit


Fitbit, a leading manufacturer and marketer of health-tracking watches, launched a study aiming to create an algorithm to detect COVID-19 before symptoms appeared. Out of the 100,000


USFDA grants CINtec PLUS Cytology test of Roche for screening of cervical cancer


Roche was awarded by US Food and Drug Administration (FDA) grant for CINtec PLUS Cytology for the 1st biomarker-based triage test for women whose primary cervical cancer sc


Warning of Cancer can be done by Blood test for microbial DNA


A new study advertised in the journal Nature on March 11, 2020, could change the currently held aspects on cancer causation and diagnosis. The researchers have come up with


Genetic test could assist doctors in identification of patients with ultra-high risk multiple myeloma


A novel genetic test could assist doctors in picking out patients with the bone marrow cancer multiple myeloma that is at 'ultra-high risk' of their cancer progressing aggr


XCR Diagnostics receives US patent for technology that expedites testing and recognition of infectious diseases


A molecular diagnostics company known as XCR Diagnostics has been granted a patent by the United States Patent and Trademark Office (US PTO) for its technology that expedit


Silfradent Srl received warning letter


An inspection has been performed at firm located in Santa Sofia, Forli-Cesena, Italy, on July 29, 2019 to August 1, 2019, an investigator from the United States Food and Dr


Regulation of Medical device in Japan and India discussed at 4th India-Japan Medical Products Regulatory Symposium


Regulatory and Clinical trial supports for innovative drug development in Japan, latest upbeat of clinical trial needs in pre and post marketing phase in India, and medical


Newly created mobile app aids in reduction of pain in osteoarthritis patients


By conducting a few simple physical exercises routinely, and getting data about their disease regularly, 500 osteoarthritis patients were able to on average halve their pai


Excillum introduces the NanoTube N2 - the X-ray resolution revolution continues with higher voltage and more power


Excillum which is Stockholm-based Company declared the introduction of a new generation high-resolution X-ray tubes.

The Excillum NanoTube N2 110 kV and N


Bio-ADM of Sphingotec can reliably assist physicians in recognizing high-risk sepsis patients


Diagnostics company SphingoTec GmbH announced on new information on the utility of endothelial function biomarker bioactive Adrenomedullin (bio-ADM®). The data demonstr


SCTIMST creates intracranial flow diverter stent for treatment of aneurysms of blood vessels of brain


The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, which is an institute of national importance, has created an innovative intr


CryoLife receives CE Mark for E-vita Open NEO hybrid stent graft


A leading cardiac and vascular surgery company known as CryoLife, Inc., committed on aortic disease, declared that it has achieved CE Mark for the E-vita Open NEO, a hybrid sten


Recalling of Alaris System Infusion Pumps by Becton Dickinson (BD) CareFusion 303 Inc.


The Alaris System is vital signs monitoring system and an infusion pump. The infusion pumps deliver medications, fluids, blood and blood products into the body of a patient


Novel AI system can access endoscopic observations of ulcerative colitis with accuracy


Evaluations of patients with ulcerative colitis (UC), which is a kind of inflammatory bowel disease, are usually performed via histology and endoscopy. But now, researchers


Draft Medical Devices Bill for stakeholders review soon will be circulated by Niti Aayog


To talk about the regulatory vacuum and issues of patient safety in medical devices, Niti Aayog is likely to spread a draft of the Medical Devices Bill for stakeholders review to fra


Merck introduces LANEXO system to increase productivity of scientists in laboratory


A leading science and technology company, Merck, inaugurate its LANEXO Lab Inventory, safety and compliance management system which is a new digital laboratory informatics solut


Elecsys GALAD score of Roche gains US FDA breakthrough device designation to diagnose HCC


Roche declared that the US Food and Drug Administration (FDA) has approved Breakthrough Device Designation to the Elecsys GALAD score. This algorithmic score cumulates gender and age


SCTIMST creates device for non-surgical closure of atrial septal defect in heart


An institute of national importance, the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, has created a nickel-titanium allo


An App was developed by researchers for Predicting Risk of Preterm Birth


An enhanced mobile phone app will aid in identifying women who require special treatments at the right time and lower the emotional and financial burden on families and the


Avanos receives FDA clearance for COOLIEF Radiofrequency system


Avanos Medical has gained clearance from the US Food and Drug Administration (FDA) for selling its 80W COOLIEF Radiofrequency (RF) system for neurological lesion procedures


Cynosure gained FDA clearance for RF micro-needling device


A US-based medical device company known as Cynosure is committed on medical aesthetics, has gained regulatory clearance from the US Food and Drug Administration (FDA) for i


FDA grants heart and lung support system of Novalung


The US Food and Drug Administration (FDA) has granted Novalung, a heart and lung support system created by Fresenius Medical Care North America (FMCNA) to treat acute respi


For Critically-ill Patients, FDA grants Heart and Lung Support System


Novalung® has been cleared by the U.S. Food and Drug Administration (FDA) which is a heart and lung support system to treat acute respiratory or cardiopulmonary failure


FDA approves breakthrough status to RESPMETER device of Altair Medical


RESPMETER wearable biosensor device of Altair Medical has been granted Breakthrough Device status by the US Food and Drug Administration (FDA) in an effort to manage the gl


FDA awards marketing authorization for Fragile X Syndrome test


The US Food and Drug Administration (FDA) has awarded marketing authorization to Asuragen for its AmplideX Fragile X Dx and Carrier Screen Kit to assist in identifying Frag


First Genetic Test for Diagnosing Fragile X Syndrome granted by FDA


The U.S. Food and Drug Administration today granted marketing of the first test for the detection of a genetic condition known as Fragile X Syndrome (FXS), the most common known


New Device engineered for treatment of Intracranial Aneurysms achieved CE Mark Approval


A new device to treat of intracranial aneurysms, Contour Neurovascular System has achieved European CE Mark approval, declared medical device company Cerus Endovascular. Th


As per the Ministry of Chemical and Fertilizers, Violation of Price Capping of Coronary Stent has been done to Attract NPPA Action


The Ministry of Chemical and Fertilizers recently announced the Parliament that if any violation of price capping relating to Coronary Stents is found by the National Pharm


As per ICRA, medical devices to be brought under Drugs Act to assist in medical device regulation effectively


ICRA has co


Novacyt, an Anglo-French Company introduces CE-IVD Marked Novel Coronavirus Diagnostics Test


Novacyt, an Anglo-French Company specializes in clinical diagnostics currently declared that its molecular diagnostics division, Primerdesign, has introduced its CE-Mark mo


Continuous Wearable BP & Vital Signs Monitor with ECG Patch


A Wireless Vital Signs Monitor and Continuous Blood Pressure & with ECG Patch has been commercialized for use of patients. This is developed by Caretaker Medical, a lea


FDA grants Eko cardiology technology advancement


Prior this month, Eko, an artificial intelligence (AI) digital health company, was approved FDA approval for its latest cardio-technology.

The US-based co


Prediction of Death Due to Stroke and Heart Attack can be done by AI with Cardiac MRI


University College London Researchers have utilized artificial intelligence for the first time to instantly and precisely measure blood flow. Utilization of Artificial inte


Health ministry furnishes notification to maintain all medical devices under D&C Act from April 1, 2020


Union health ministry has announced that all medical devices will now be maintained under the Drugs and Cosmetics (D&C) Act, 1940 with effect from the April 1, 2020 for


FDA approves 510(k) clearance to MRI system of Hyperfine Research


The US Food and Drug Administration (FDA) have approved 510(k) clearance to bedside Magnetic Resonance Imaging (MRI) system of Hyperfine Research.

The fir


Surgical System of TransEnterix’s Senhance receives CE Mark approval


Medical device company TransEnterix has obtained CE Mark approval for an extended indication of the Senhance Surgical System for treatment of paediatric patients weighing a


FDA grants mobile app of Orthofix for bone growth stimulators


Orthofix Medical declared today that it gained FDA approval for its STIM onTrack mobile app version 2.1 for utilization with its bone growth stimulators.


Progression of Parkinson's disease can be predicted by simple Blood test


Researchers have observed that a blood test for cell senescence biomarkers and inflammatory may be a reliable predictor of cognitive decline, involving identifying those wh


FDA approves Surfacer System De Novo clearance of Bluegrass Vascular


The US Food and Drug Administration (FDA) have approved a De Novo clearance to Surfacer Inside-Out Access Catheter System engineered by private medical technology company B


Medical devices to be maintained as drugs


All medical devices marketed in the country will now be maintained as ‘drugs’, and come under the purview of the Drugs and Cosmetics Act. The government stated


Bringing MRI to Bedside in Stroke Patients using portable MRI


At current scenario patients have to move to a location of a high-field MRI device for diagnosis of stroke causing vital delay in diagnosis. However, Advancement in low-fie


icometrix gains FDA approval for icobrain ep solution


icometrix has gained 510(k) clearance from the US Food and Drug Administration (FDA) for its icobrain ep solution.

Icobrain ep assists in identification o


First medical device for usage in U.S by SA biotech cleared by FDA


Bluegrass Vascular Technologies has gained regulatory approval from the Federal Drug Administration to provide its medical device on the market in the U.S. roughly 9 years


Marketing approval obtained by cardiac ultrasound software of Caption Health


Caption Health has gained authorization from the US Food and Drug Administration (FDA) for marketing its cardiac ultrasound software.

Caption Guidance, th


FDA provides OTC clearance to INNOVO of Atlantic Therapeutics for SUI


The US Food and Drug Administration (FDA) have provided over-the-counter (OTC) clearance to INNOVO of Atlantic Therapeutics, a non-invasive and wearable device for stress u


FDA breakthrough designation received by Aria CV for Its medical device to treat pulmonary arterial hypertension


A developer of medical devices, Aria CV, Inc., for treating Pulmonary Arterial Hypertension (PAH), today declared that they have secured from U.S. Food and Drug Administrat


MRI-compatible products by Imricor receives CE mark approval


Vision-MR Ablation Catheter and Vision-MR Dispersive Electrode get CE mark approval to conduct cariac catheter ablations using real-time MRI. Imricor is the first company to have car


FDA 510(k) clearance to BioSticker


The BioSticker™ on-body sensor for scalable remote care by BioIntelliSense Inc. receives the FDA 510(k) clearance.

 A new standard for remote patient monitoring is


AI tool to recognize modifications in patients' mental health


Researchers, involving one of Indian-origin, have created an artificial intelligence (AI) tool that can precisely detect modifications in clinical states in voice data of p


Siemens reveals medical manufacturing centre in Bangalore


Siemens Healthineers which is a medical technology company has initiated its first manufacturing facility in Bengaluru, which will complement its existing R&D centre. T


Novel 'smart' chair aids in correcting body posture from childhood


The concept of the current study is already submitted in the conference materials furnished by the French publishing house Atlantis Press, contented by the Scopus and


Team discovers a way to eliminate GI device without the usage of endoscopy


Scholars at Massachu


Fitness tracker devices demonstrate potential as predictors of flu outbreaks


Scholars at Scripps Research Translational Institute have discovered that fitness tracker devices – wearable tracker devices that calculate heart rate and sleep durat


Pentax Medical receives FDA approval for IMAGINA endoscopy system


A unit of Hoya Group, Pentax Medical, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its IMAGINA endoscopy system.

The endoscopy platform wa


Medtronic gains CE Mark approval for InterStim products


Medtronic which is Irish medical device maker has secured CE Mark approval for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.

By giving full-body MRI s


Clearance of new AI system from FDA for spotting stroke


501(k) clearance has been granted to the US Food and Drug Administration (FDA) for radiology company Aidoc’s AI-based system for the recognition of large-vessel occlusion (LVO)


Phagenesis gains FDA breakthrough green light for Phagenyx System for restoring swallowing


Phagenesis declared that it has secured breakthrough device designation from the FDA for its Phagenyx System for restoring neurological swallowing control.

The Phagenyx Syste


New Guidance advertised on Medical Devices and Cybersecurity


New European medical device guidance will need manufacturers to carefully review IT security and cybersecurity needs in relation to their devices and in their product literature


Breakthrough Therapy Designation filed by CytoDyn with the FDA for the Utilization of Leronlimab to treat Metastatic Triple-Negative Breast Cancer


A late-stage biotechnology company known as CytoDyn Inc. is committed on developing leronlimab (PRO 140), a CCR5 antagonist with the capability for multiple therapeutic ind


Researchers created AI system to locate and grade prostate cancer


Researchers have created a method addressed on artificial intelligence (AI) for diagnosis and grading of prostate cancer.
The AI-system has the capability to solve one of t


URO17 bladder cancer recurrence test of KDx Diagnostics obtains USFDA breakthrough device designation


KDx Diagnostics, a company committed on developing non-invasive cancer tests to enhance early detection and therapy decisions in cancer, declared that the Food and Drug Adm


Silver Bullet achieves CE Mark for antimicrobial bone screw system


Silver Bullet Therapeutics which is US-based medical device company has gained CE Mark approval for the commercial sale of its antimicrobial bone screw system in the European Union (


Reflow receives breakthrough designation for spur stent system


Reflow Medical has obtained breakthrough device designation for its Temporary Spur Stent System from the US Food and Drug Administration (FDA).

The retrievable stent tec


Abbott obtains FDA approval for procedure of heart pump implant


Abbott has gained approval from the US Food and Drug Administration (FDA) for its minimum invasive heart pump implant procedure to assist patients in avoiding open heart surgery


USFDA grant approval to Abbott's HeartMate 3 heart pump to aid patients avoid open heart surgery


Abbott declared that the US Food and Drug Administration (FDA) has granted approval to a new alternative surgical technique for Abbott's HeartMate 3 heart pump that will permit


Cognetivity Neurosciences declares regulatory approval of 1st CE-marked medical device


Cognetivity Neurosciences Ltd. declared that its Integrated Cognitive Assessment (ICA) software has been granted as a CE-marked medical device. The declaration follows Cognetivi


FDA grants 510(k) clearance for handheld OCT scanner of PhotoniCare


510(k) clearance for PhotoniCare’s TOMi Scope has been granted by the US Food and Drug Administration (FDA) for non-invasive imaging of the middle ear to diagnose ear infe


Bioness gains CE Mark approval for StimRouter system


Bioness, a US-based medical technology company has gained CE Mark approval for its StimRouter neuromodulation system for treatment faecal incontinence.

The small implant


FDA grants approval for Control-IQ artificial pancreas system


The U.S. Food and Drug Administration has granted approval for an artificial pancreas system that automatically regulates and monitors blood sugar levels.

The system is addre


MyShoulder placement guides of Medacta cleared by FDA


Medacta obtains FDA clearance for their MyShoulder Placement Guides for shoulder arthroplasty. This patient-compatibility, 3D printed solutions work in co-existence with the Medacta


IIT-Roorkee makes a bioresorbable, economical ortho implants for healing of bone fractures


Scholars and researchers at the Indian Institute of Technology (IIT), Roorkee have made bioresorbable and economical orthopaedic implants to heal bone fractures.

The recent s


Invention of cost-effective bio-resorbable orthopaedic implants by IIT Roorkee for healing bone fractures


Invention of cost-effective bio-resorbable orthopaedic implants for healing bone fractures were done by the researchers of IIT Roorkee. The recent strategies of therapeutic to h


Ultrasound along with MRI enhances prostate treatment


MRI-guided transurethral ultrasound ablation (TULSA) is a novel tool for the highly precise treatment of prostate cancer — without the common side effects. Scans of ultras


First indigenous CT-scanner shipped by Siemens Healthineers from its new Bengaluru facility

Siemens Healthineers has shipped its 1st indigenous CT scanner from its currently launched prior art medical imaging factory in Bengaluru. The Somatom g


For 24 hours health monitoring tiny microsensor implants has been developed


Researchers at National University of Singapore (NUS) have created tiny subcutaneous implants that can continuously quantify a heart rate, blood sugar and other physiological conditi


Implants specific to patients are developed at Central Scientific Instruments Organisation


Jaw and bone implants specific with patients can now be developed and created within the country, inside IARM (innovative additive research and manufacturing) laboratory establi


FDA clearance secured by Life Spine to market Titanium Stand-Alone ALIF Spacer System


FDA 510(K) Clearance secured by Life Spine for the Titanium Stand-Alone ALIF System. It is the 7th product of the company to obtain FDA approval this year.

The Tita


As per 2013 standards Accu-Chek blood glucose monitoring systems are in compliance with latest IS/ISO 15197


Roche Diabetes Care (RDC) India declared that its Accu-Chek brand of blood glucose monitoring products are in compliance with the revised standards of IS/ISO 15197:2013. It has


A preoperative blood test may anticipate risk of cardiac complications after surgery


The number of surgical interventions is on the elevation and together there is an enhancement in number of postoperative complications.

Of all the patients who have undergone


New Software System for Insulin Control was granted by FDA


Tandem Diabetes Care has secured approval in the US for a new software system that can be utilized in “artificial pancreas” systems to automatically measure blood glucose


Recalling of vagus nerve implant by LivaNova amid reset issues


LivaNova is calling back its vagus nerve stimulation (VNS) device that is implanted in patients for treatment of major depressive episodes and to control seizures related with epilep


Prevention of ICU delirium and improvement in patient outcomes led by new developed software


Intensive care unit delirium which is a fertile area of clinical research and patient care innovation related with Vanderbilt University Medical Center, is initiating to reshape how&


Novel genetic test may anticipate ischemic stroke at birth


Major cause of death and permanent disability worldwide is stroke. About 80% of strokes are “ischemic” — meaning, they are caused due to the blockage of an artery t


Novel AI app may prohibit patients from severe falls


A novel machine learning app has been created for prohibiting patients from severe fall-related injuries and deaths. Houston Methodist have created novel AI technology whic


Renewed CE mark gained by IRRAS for IRRAflow catheter


IRRAS received CE mark approval for its IRRAflow catheter. The new approval is gained after the company obtained 2 CE marks for its IRRAflow system’s tube set with a digital pu


Recalling device by LivaNova for treatment of seizures, depression


Recalling of device by LivaNova is done which is London medical device-maker that helps in treatment of adults and children over 4 years old with partial onset seizures that hav


Bristol-Myers Squibb obtains USFDA approval for CAR T cell therapy for treatment of LBCL patients


Bristol-Myers Squibb Company declared the filing of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for lisocabtagene maraleucel (liso-cel


EB19-J10U Ultrasound Video Bronchoscope released by PENTAX in United States


PENTAX received the USFDA clearance for its new EB19-J10U endobronchial scope. The device, proposed for minimally invasive procedures such as EBUS-guided Transbronchial Needle A


Testing Clearance in EU for FINDER Device for Bedside G6PD Deficiency


Baebies has secured the CE Mark for its FINDER device, paving the way for Europe introduction. The device can render in identifying Glucose-6- Phosphate Dehydrogenase (G6PD


AiMeD praised proposed medical devices bill by Niti Aayog to consider patient safety


Association of Indian Medical Device Industry (AiMeD) praised proposed medical devices bill by Niti Aayog to consider safety of patient and import dependency issues. Its objecti


FDA breakthrough nod secured for Mayo Clinic which has AI-based heart failure screening from Eko


Eko which is Digital Health Company secured breakthrough device designation from FDA for priority review of the algorithm to detect heart failure of company with a specialized stetho


FDA advises Conformis over sterilization cycle failures


FDA proclaimed regarding a warning letter to Conformis, a Massachusetts-based customized joint implant manufacturer, quoting sterilization issues regarding the knee replacement syste


Breakthrough status granted to Eko’s ECG-based algorithm by FDA


Eko Devices which is a digital health firm has gained breakthrough device designation from the US Food and Drug Administration (FDA) for its ECG-based low ejection fraction screening


Medfusion® 4000 Syringe Pumps Recalled by Smiths Medical ASD, Inc. Due to Malfunctioning Alarms and Potential Interruption of Therapy


The FDA has recognized the recall as a Class I recall which is the most serious type of recall. Utilization of these devices may cause morbidity or mortality.

The Smiths Medi


FDA Clearance obtained by TAP At-Home Blood Collection System


Seventh Sense Biosystems secured FDA clearance for its TAP device to be utilized by laypersons for collection of blood.The device is now given green signal to be utilized at home by


FDA Clearance for Cranial Procedures of Medtronic Stealth Autoguide System


A cranial robotic platform from Medtronic which is the Stealth Autoguide has been given clearance by the FDA. The system renders accurate and partially automatic positioning and adva


AI-driven prostate launched by Anixa Biosciences for cancer detection test


Anixa Biosciences has commercially introduced Cchek Prostate Cancer Confirmation (Cchek PCC) test. The low-cost blood test is considered to accurately identify the existence of cance


CE Mark obtained by Aleva Neurotherapeutics for brain stimulation system


Aleva Neurotherapeutics has obtained CE mark for its directSTIM Deep Brain Stimulation (DBS) system. The DBS system technology permits accurate steering of current towards the desi


AI assisted polyp detector of Pentax Medical, Discovery obtains CE marking


A division of the Hoya Group, Pentax Medical received CE mark for Discovery, an innovative Artificial Intelligence (AI) assisted polyp detector structured to support endoscopists in


OmniBeds and Giraffe Incubators are recalled by GE Healthcare Recalls Due to Potential for Infants to Fall


The FDA has recognized this as a Class I recall which is the most serious type of recall. Utilization of these devices may cause morbidity or mortality. 

Warmers an


CrossCath® Support Catheters recalled by Cook Medical Due to a production Error Which May Cause the Marker Bands to Dislodge or Cause hooking


The FDA has recognized this as a Class I recall which is the most serious type of recall. Utilization of these devices may cause morbidity or mortality.

The CrossCath&re


Zika blood screening test introduced by Roche


Roche has declared the launch of its cobas Zika test to markets that are in compliance with the CE mark. The cobas Zika test, which is proposed for use in screening blood donati


Tandem gains FDA clean chit for 1st interoperable, automated insulin software for dosing


FDA granted the third and final type of diabetes management technology necessary for a wholly inter-operable, automated insulin system for dosing.
The clearance of De Novo went


Boston Scientific receives first US disposable duodenoscope clearance


510(k) clearance was granted by FDA to the 1st ever wholly disposable duodenoscope which is a device developed by Boston Scientific.
Jeff Shuren who is the Health Director of Ce


SynchroMed II Implantable Drug Infusion Pump Recalled by Medtronic


Currently, FDA released a report that Medtronic has recalled its SynchroMed II implantable drug infusion pump, part of the SynchroMed Infusion System, after obtaining reports of


FDA Approves First Disposable Duodenoscope which Reduces Risk of Infection


When duodenoscopes which are utilized for diagnosis of illness in the pancreas and bile ducts are not cleaned properly, can cause hundreds of cases of severe, sometimes fatal, infect


FDA grants tool for evaluating safety of implanted devices


An announcement was done regarding FDA securing a tool which is created to make it simpler for developers of active implantable medical devices (AIMDs) to make safety test results.


SynchroMed II Implantable Drug Infusion Pump Recalled by Medtronic


Due to the potential availability of Foreign Particles Inside the Pump Motor Assembly Which May result in Pump Motor Stall Part of the SynchroMed Infusion System which is known as


FDA approval to Cochlear for conduction of bone implant


Cochlear has obtained clearance from the US Food and Drug Administration (FDA) for its Osia 2 implantable conduction hearing system of bone.
Connection between the Osia OSI200 I


LimaCorporate, TechMah Medical obtain USFDA 510k approval for Smart SPACE Shoulder 3D Planner & 3D Positioner


A global medical device company known as LimaCorporate obtains the FDA 510K approval for Smart SPACE Shoulder 3D Planner & 3D Positioner. Being an innovative digital platform, Sm


Breakthrough designation to Beta Bionics for blood sugar device


Breakthrough device designation status has been obtained by Beta Bionics from the US Food and Drug Administration (FDA) for its iLet Bionic Pancreas System. iLet Bionic Pancreas is a


CE mark received by Roche for blood glucose monitoring app


CE mark has been granted to Roche for its smartphone app that permits users to quantify blood glucose level without the requirement of a meter. This is known as Accu-Chek SugarVie. T


FDA labelled breakthrough device to Beta Bionics' pancreas tech


Boston-based medtech Beta Bionics received FDA Breakthrough Devices Program for its iLet system, which utilizes mathematical algorithms for dosing to automatically control blood suga


FDA scores novel Medtronic SynchroMed II call back as Class I event


As per the reports released by agency, FDA classified a Medtronic voluntary call back of certain SynchroMed II implantable drug infusion pumps as a Class I event.

The recall,


FDA recommends option 510(k) criteria for MRI coils


Issuance of a draft guidance document was done by FDA describing the performance criteria that producers of radio frequency coils for magnetic resonance imaging (MRI) can utilize to


Breakthrough therapy designation received by Bristol-Myers Squibb's ORENCIA from US FDA


Breakthrough Therapy Designation was granted by the US Food and Drug
Administration (FDA) to Bristol-Myers Squibb Company for ORENCIA (abatacept) for the moderate to severe acut


Regulatory Approval to Mainstay Medical from Australian Therapeutic Goods Administration (TGA) for ReActiv8


Mainstay Medical International received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for ReActiv8, its implantable restorative neurostimulation syst


Cobas vivoDx MRSA of Roche Molecular System receives approval from FDA


Marketing approval has been granted by the US Food and Drug Administration (FDA) for cobas vivoDx, MRSA of Roche Molecular System which is a diagnostic test that helps in the detecti


FDA clearance obtained by Sight Diagnostics for Olo blood analyser


Sight Diagnostics  had obtained clearance from the US Food and Drug Administration (FDA) for its Olo blood analyser, which is able to process results for a complete blood test i


BioPrax, Infection-Eradicating was tagged ‘Breakthrough’ by USFDA


“Breakthrough Device” designation has been granted to Garwood Medical Devices, LLC, from the U.S. Food and Drug Administration (FDA) for the BioPrax device of the company


Surgical robot of Vicarious obtains breakthrough status by FDA


Vicarious has managed to secure breakthrough device status from FDA for Surgical's robotic surgical system. The status, is the 1st awarded to a surgical robot, blankets technology st


afib device of Boston Scientific efficient in reduction of stroke


FDA-mandated registries had 2 long-term studies which are associated to Boston Scientific's left atrial appendage closure device known as Watchman, to vital reductions in stroke risk


FDA approval received by HealthLytix for prostate imaging software


510(k) clearance has been granted by the US Food and Drug Administration (FDA) for breakthrough prostate imaging software, RSI-MRI+ of HealthLytix.

The approval holds a


System for the delivery of ear tubes approved by the FDA for local anesthesia to treat ear infection


An approval was granted by the USFDA to a new system for the delivery of tympanostomy tubes, commonly known as ear tubes that can be inserted into the eardrum for treatment of the re


Breakthrough Therapy Designation for MDD received by Psilocybin


Usona Institute, Madison, Wisconsin, was recently granted with the Breakthrough Therapy designation for psilocybin by the US Food and Drug Administration (FDA) for the treatment of p


Renovia obtains FDA approval for Pelvic Digital Therapeutic


510(k) clearance has been granted by the US Food and Drug Administration (FDA) for next- generation leva Pelvic Digital Therapeutic device of Renovia.
The therapeutic device of


Novel treatment for targeting abnormality in sickle cell disease approved by FDA


An accelerated approval was granted by the USFDA to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older. The


FDA 510(k) Clearance received by US Medical Innovations for the Canady Plasma Smart XL- 1000 Generator


A Biomedical and Life Science subsidiary of US Patent Innovations, LLC (USPI) known as US Medical Innovations, LLC (USMI), obtained the U.S. Food and Drug Administration (FDA) 510(k)


BRAC Analysis diagnostic system of Myriad Genetics received Japanese nod for breast cancer patients


Japan’s Ministry of Health, Labour and Welfare (MHLW) has given consent to the BRACAnalysis Diagnostic System (i.e., “BRACAnalysis”) to render physicians deter


FDA approves first contact lens to slower the progression of nearsightedness in children


First contact lens has been approved by the U.S. Food and Drug Administration stipulated to slower the progression of myopia (nearsightedness) in children between the ages of 8


FDA cleared first Duodenoscope with Sterile, Disposable Component


The first duodenoscope with a sterile, disposable elevator piece was cleared for marketing by the US Food and Drug Administration (FDA). The components of disposable elevator wi


Stryker obtains US FDA 510(k) clearance for SAHARA lateral 3D expandable interbody system


Stryker, has receive the 510(k) clearance of its SAHARA Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology, from the US Food and Drug Administration (FD


FDA clearance for hands-free XACT robotic system


Clearance for marketing has been granted by the US Food and Drug Administration (FDA) to XACT Robotics’ hands-free robotic system for usage in Computed Tomography (CT) guided p


Impulse Device receives PMA approval from FDA for heart failure device


PMA supplement approval was received by Impulse Dynamics for its next-generation; two lead Optimizer Smart System for treatment of heart failure by the US Food and Drug Administratio


Medical Device Developments: Finalization of Four 510(k) Guidance Documents by FDA


The U.S. Food and Drug Administration furnished multiple final guidance documents related to the medical device program. Here are the four guidance documents: final guidances on the


Draft Medical Devices Amendment Rules released by CDSCO for medical devices registration


Draft Medical Devices Amendment Rules, 2019 for registration of thirty six medical devices based on the Drugs Technical Advisory Board (DTAB) suggestions were released by the Union h


All medical devices to be brought under CDSCO to improve safety & quality


As per the government plans, all medical devices, including implants and contraceptives are to be brought under the Central Drugs and Standard Control Organisation to ensure improvem


US FDA approval to Secuado transdermal system of Noven Pharma for treating adults with schizophrenia


The US Food and Drug Administration (FDA) approval has been given to Secuado (asenapine) transdermal system which is the first-and-only transdermal patch formulation for the treatmen


6 months transition time approval to implement provisions of new Medical Device Rules, 2017


A transition time of 6 months has been approved by the Union health ministry for implementing provisions of new Medical Device Rules, 2017 for the requirement of switching inventory


US FDA approval to OssDsign for marketing Cranial PSI Accessories in US


The US Food and Drug Administration (FDA) has granted 510(k) clearance (K190523) for marketing OssDsign Cranial PSI Accessories in the US. The products which are cleared are a set of


Guidelines on performance evaluation of IVDs for grant of manufacturing and import licenses issued by CDSCO


Guidelines has been issued by the Central Drugs Standard Control Organisation (CDSCO) for evaluation of performance of In-Vitro Diagnostic (IVD) medical devices for grant of manufact


Breakthrough Device Designation for Heart Failure to Corvia Medical's Interatrial Shunt Device (IASD®)


A privately-held company, Corvia Medical, Inc., which has a first-in-class structural heart device for treatment of heart failure has received the Breakthrough Device designation by


NHS approval to Genedrive for baby deafness trial test


Genedrive a molecular diagnostics firm has obtained approval from the NHS Health Research Authority and ethics committee for the usage of the Antibiotic Induced Hearing (AIHL) test i


FDA Clearance to Biofourmis Analytics Engine for Ambulatory Physiologic Monitoring


Biofourmis has obtained 510(K) clearance for its machine-learning and artificial intelligence (AI)-powered analytics engine as a medical device for ambulatory physiological monitorin


FDA clearance obtained by for mobile-based CKD test

The test of can be performed at pharmacies, urgent care centres and health clinics, which eliminates the need for a tabletop lab device.

Furthermore, the test can also present im


FDA breakthrough device designation to Novel system for PAH

A breakthrough device designation has been granted by the FDA to a therapeutic intravascular ultrasound system for patients with pulmonary artery hypertension.

A therapeutic ultrasound cath


Moderato system wins CE Mark for treating hypertension: Orchestra

Orchestra BioMed, Biomedical company has received European CE-Mark approval for its Moderato implantable pulse generator system to treat patients with hypertension.

Moderato functions with


FDA granted breakthrough device designation to MagicTouch AVF sirolimus-coated balloon

FDA granted the breakthrough device designation for MagicTouch AVF, its sirolimus drug-coated balloon (DCB) catheter used for treating the stenotic lesions of arteriovenous fistulae or arteriovenou


US FDA breakthrough device status to Conceptualize Medical's Sirolimus DCB catheter, MagicTouch AVF

Concept Medical Inc. (CMI) wins US Food and Drug Administration (FDA) grant as “Breakthrough Device Designation” for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, fo


FDA approval to ApiFix MID-C system to treat adolescent idiopathic scoliosis

The US FDA has approved ApiFix for the commercialization of Minimally Invasive Deformity Correction (MID-C) system. This approval has been done through Humanitarian Device exemption for the treatme


Minimally Invasive Deformity Correction (MID-C) System - H170001 wins approval: USFDA

Minimally Invasive Deformity Correction (MID-C) System gets the USFDA approval to treat adolescent patients having idiopathic scoliosis. The intention of non-fusion spinal device known as Minimally


SAPIEN 3 Ultra Delivery System Recall by Edwards Lifesciences, LLC

The SAPIEN 3 Ultra delivery system of Edwards is being recalled by the organization. It is required for delivering and deploying the Edwards SAPIEN 3 Ultra transcatheter heart valve or the Edwards


Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Recall: Medline Industries, Inc.

An announcement has been made regarding the recalling of Medline Primary Warmer Pack and Primary Set Pack which is used to help in the administration of intravenous (IV) fluids. 

The M


Centurion Medical Products' Primary Warmer Pack by Medline Industries, Inc. Recalled

An announcement has been made regarding the recalling of Medline Primary Warmer Pack, which is used to help in the administering of intravenous (IV) fluids. The Medline Primary Warmer Pack constitu


MED-EL Cochlear Implant System - P000025/S104 wins USFDA approval

The MED-EL Cochlear Implant System gets the USFDA approval to produce auditory sensations. The intention of MED-EL Cochlear Implant System is to produce auditory sensations by giving electric stimu


PD-L1 IHC 22C3 pharmDx - P150013/S016 wins USFDA approval

The lab test used by doctors for checking the protein programmed cell death ligand 1 (PD-L1) in tumor tissue obtained from patients, who have esophageal squamous cell cancer is done by PD-L1 IHC 22


Medical device manufacturer can now ask for FDA feedback after inspection

The FDA has notified in a draft that in coming times, they will offer nonbinding feedback after completion of their inspection at medical device manufacturer.

The FDA explained the complete


First spinal tether device wins the USFDA approval for treating idiopathic scoliosis

The US FDA has given the approval to first spinal tether device to be used in adolescents and children having idiopathic scoliosis. It is an alternative to surgical treatment.

The Zimmer Bi


The Tether™ - Vertebral Body Tethering System - H190005 grabs USFDA approval

The USFDA approval is granted to the Tether-Vertebral Body Tethering system. The intention of non-fusion spinal device known as Tether™ - Vertebral Body Tethering System is to treat idiopathi


Medtronic CoreValve System; Medtronic CoreValve Evolut R System; Medtronic CoreValve Evolut PRO System - P130021/S033 gets approval from USFDA

The USFDA gives the approval to CoreValue system developed by Medtronic. Three design iterations are present in the Medtronic CoreValve family of devices: the Medtronic CoreValve System (1st genera


USFDA approves Edwards SAPIEN 3 Transcatheter Heart Valve System - P140031/S085

The SAPIEN 3 Transcatheter Heart Valve (THV) System and Edwards SAPIEN 3 Ultra THV System of Edward, both consist of an artificial catheter-based aortic heart valve and accessories used for implant


BAROSTIM NEO System - P180050 wins USFDA approval

Barostim NEO system gets the USFDA approval to treat advanced heart failure. An implantable pulse generator (IPG), a carotid sinus lead kit and a programmer are included in the BAROSTIM NEO System.


FDA Breakthrough designation to V-Wave's Interatrial Shunt regarding Device Designation for Heart Failure

A privately held medical device company known as V-Wave Ltd., developing new implantable interatrial shunt devices receives the Breakthrough Device Designation from the U.S. Food and Drug Administr


Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Recall: Fresenius Kabi

Fresenius Kabi announced the recall of Volumat MC Agilia Infusion System which is an infusion pump used by health care professionals that delivers fluids including medications, blood, and blood pro


NvisionVLE Imaging System wins FDA clearance


NvisionVLE Imaging System can now be marketed by NinePoint Medical following clearance from the US FDA. It can give high-resolution volumetric images of the sub


CE marking to Meril Life Sciences for bioresorbable scaffold stent

Meril Life Sciences receives CE marking for their scaffold -MeRes100 BRS, becoming the first thin-strut bioresorbable scaffold. 

Cardiovascular related diseases such as coronary artery


USFDA approves Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System - P130021/S058

Both of the sytems, the Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO gets the USFDA approval. Both consists of a transcatheter aortic valve (TAV), a delivery catheter, and


CE Mark approval wins by ExThera for Seraph 100

Seraph 100 by ExThera Medical, developed for pathogen reduction during bloodstream infection gets the CE Mark approval. Obtaining the CE mark approval confirms the safety of Seraph 100.



Abbott recalls Ellipse Implantable Cardioverter Defibrillators

Implantable cardioverter defibrillators with model numbers CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C, CD2411-36Q manufactured between 05 April 2019 till 29 May 2019 are bein


OncoBEAM RAS CRC kit gets Japanese approval

Sysmex Corporation achieves the Japanese approval to manufacture and market OncoBEAM RAS CRC Kit. It is used in the patients of colorectal cancer for blood-based circulating tumour DNA molecular te


OncoBEAM RAS CRC kit gets Japanese approval

Sysmex Corporation achieves the Japanese approval to manufacture and market OncoBEAM RAS CRC Kit. It is used in the patients of colorectal cancer for blood-based circulating tumour DNA molecular te


Medical device manufacturing sites will be audited by 6 bodies: CDSCO

According to the new MD Rules, the 6 bodies are notified by the CDSCO to audit the medical device manufacturing sites.

The new MD Rules 2017 became effective since 01 January 2018. These ru


Filter Tips by QIAGEN recalled due to inaccurate or delayed results

1500 µl filter tips to be used with QIAGEN QIAsymphony SP/AS instruments, model number REF 997024 with lot number 0605020019 and 0605020020 are recalled due to delayed or incorrect results.


FDA Draft guidance on Medical Device’s Safety in MRI Environment

A new draft guidance namely Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment has been issued by the U.S. Food and Drug Administration (FDA).



USFDA: Green signal to PD-L1 IHC 22C3 pharmDx - P150013/S014

The USFDA grants green signal to PD-L1 IHC 22C3 pharmDX. The lab test used by doctors for checking head and neck squamous cell cancer having programmed cell death ligand 1 (PD-L1) in their cancer i


Welch Allyn RetinaVue 700 Imager Launched by Hillrom

Hillrom launches the Welch Allyn RetinaVue 700 Imager, a retinal camera to detect diabetic retinopathy. It is a recent innovative diagnostic technology.

It helps distant ophthalmologists to


Delivering accurate chest compression now becomes easy
The researchers from University of Applied Sciences and Fraunhofer Institute for Silicate Research have developed a device, named Rescue Aid. It assists in administering the ch


Improvement in Powered Prosthetic Arms by Implanted Electrodes

In recent times, few built-in electrodes are present in conventional powered prosthetic arms that make connection with skin of the patient. These are good enough to open and close a simple claw, bu


ECG, Breathing, Heart Rate measurement continuously for weeks using Flexible Body Monitor

Long-term continuous monitoring of physiological activity can impart precise information about an individual’s health. Children, elderly, and people with varied conditions often face difficul


Rescue Aid to deliver accurate chest compressions

It is well known that perfectly delivered chest compressions can save an individual from cardiac arrest. However, this is not an easy task for the bystanders to perform the resuscitation because in


Quality requirement draft on combination products: EMA

A draft guideline is published by the European Medicines Agency (MEA) on quality requirements for medical devices and medicinal products combination. This combination is also known as Drug device c


Medical device’s encryption standards ‘needs to be compulsory’

An internet of things (IoT) company has warned that it is necessary to legally enforce the encryption standards on the medical devices. Encryption is mandatory for both developers and users. This i


Johnson and Johnson’s faulty hip implants issue raised in Rajya Sabha

Anand Sharma, congress leader, requested the current government to make the regulatory norms more stringent so that the incident like Johnson & Johnson’s selling faulty hip implants shoul


Aortix system of Procyrion received Breakthrough Device Designation from FDA

The Aortix system of Procyrion Inc. has secured the Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). It is a percutaneous circulatory support system for medical-con


Medtronic’s VenaSeal Closure System unveiled in India treat CVD patients

Medtronic Private Limited has launched its VenaSeal Closure System in India to treat the people suffering from chronic venous disease (CVD). It is an invasive procedure in which the diseased vein i


MDTAG constituted by Health ministry

A Medical Devices Technical Advisory Group (MDTAG) has been constituted by the Union Health Ministry. The group will be giving advice to the Central Drugs Standard Control Organization (CDSCO) on m


Bausch and Lomb’s faulty adrenaline auto-injector gets Regulatory warning

The UK MHRA has announced in the alert letter that about 0.23% syringe pens (2.3 pens in every 1,000) manufactured by Bausch & Lomb fails to deliver adrenaline’s dose due to needle blocka


Microfluidics device developed for sepsis diagnosis

An automated, microfluidics device has been developed by the researchers from Massachusetts Institute of Technology (MIT) in the US. It will help in the detection of sepsis with 25 minutes.


Medical Device Cybersecurity Recommendations drafted by France

The draft recommendations on the cybersecurity of medical devices have been developed by France’s National Agency for the Safety of Medicines and Health Products (ANSM).

These recomme


All Intra-Aortic Balloon Pump models recalled by Maquet

The FDA has recognized the recall of Maquet/Datascope Intra-Aortic Balloon Pumps (IABP), models Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i, as the Class Ⅰ recall.



Medtronic to make’s AI stroke detection software

Medtronic, an Irish medical technology firm, has decided to make the artificial intelligence (AI)-based stroke care solutions provider’s new technology available to different centers i


First cochlear device for single-sided deafness approved by FDA

Med-El North America, a Durham, N.C.-based firm has received an approval from the FDA for its cochlear implant system. This new device is first of its kind that can be used in people with single-si


Digital Inhaler approved for Asthma patients: FDA

AirDuo Digihaler (fluticasone propionate 113mcg and salmeterol 14mcg), an inhalation powder, has been approved by the FDA. It is meant for asthma treatment in patients aged 12 years and older, but