Medical Device Newsletter

18-01-2020

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

17-01-2020

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

17-01-2020

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

17-01-2020

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

 

Scholars at Massachu

17-01-2020

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

16-01-2020

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

14-01-2020

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

14-01-2020

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)

14-01-2020

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

13-01-2020

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

13-01-2020

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

10-01-2020

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

10-01-2020

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

10-01-2020

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 (

10-01-2020

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

08-01-2020

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

08-01-2020

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

07-01-2020

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

07-01-2020

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

07-01-2020

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

02-01-2020

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

30-12-2019

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

28-12-2019

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

27-12-2019

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

26-12-2019

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

26-12-2019

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

26-12-2019

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

25-12-2019

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

24-12-2019

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

24-12-2019

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

24-12-2019

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

23-12-2019

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

23-12-2019

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

22-12-2019

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&

22-12-2019

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

22-12-2019

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

20-12-2019

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

20-12-2019

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

20-12-2019

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

20-12-2019

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

19-12-2019

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

19-12-2019

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

19-12-2019

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

19-12-2019

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

19-12-2019

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

19-12-2019

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

18-12-2019

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

18-12-2019

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

17-12-2019

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

17-12-2019

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

17-12-2019

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

17-12-2019

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

17-12-2019

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

16-12-2019

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

16-12-2019

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

16-12-2019

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

16-12-2019

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

13-12-2019

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

13-12-2019

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.

13-12-2019

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

12-12-2019

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

11-12-2019

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

11-12-2019

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

11-12-2019

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

11-12-2019

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

10-12-2019

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,

09-12-2019

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

06-12-2019

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

06-12-2019

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

06-12-2019

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

05-12-2019

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

05-12-2019

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

05-12-2019

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

05-12-2019

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

27-11-2019

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

27-11-2019

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

27-11-2019

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

26-11-2019

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

26-11-2019

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

25-11-2019

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)

23-11-2019

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

15-11-2019

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

15-11-2019

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

02-11-2019

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

01-11-2019

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

31-10-2019

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

30-10-2019

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

24-10-2019

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

18-10-2019

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

17-10-2019

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

15-10-2019

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

15-10-2019

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

14-10-2019

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

09-10-2019

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

07-10-2019

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

04-10-2019

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

12-09-2019

FDA clearance obtained by Healthy.io for mobile-based CKD test

The test of Healthy.io 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

09-09-2019

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

05-09-2019

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

02-09-2019

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

31-08-2019

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

28-08-2019

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

23-08-2019

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

22-08-2019

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

21-08-2019

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

21-08-2019

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

21-08-2019

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

20-08-2019

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

19-08-2019

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

18-08-2019

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

16-08-2019

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

16-08-2019

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

16-08-2019

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

16-08-2019

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.

15-08-2019

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

12-08-2019

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

09-08-2019

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

09-08-2019

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

09-08-2019

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

07-08-2019

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.

&nb

05-08-2019

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

05-08-2019

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

05-08-2019

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

02-08-2019

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

02-08-2019

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.

02-08-2019

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).

Unique

02-08-2019

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

01-08-2019

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

01-08-2019

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

01-08-2019

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

01-08-2019

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

01-08-2019

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

31-07-2019

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

31-07-2019

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

31-07-2019

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

30-07-2019

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

27-07-2019

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

26-07-2019

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

25-07-2019

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

24-07-2019

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.

23-07-2019

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

23-07-2019

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.

IABP, a

23-07-2019

Medtronic to make Viz.ai’s AI stroke detection software

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

23-07-2019

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

16-07-2019

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