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Medical Device Newsletter

10th July 2019

Blood flow monitor developed for heart surgery
A new micro-medical device has been developed by the researchers at Flinders University in Australia. The device will be used to continuously monitor blood flow during heart surgeries.

02nd July 2019

New and revised documents released by IMDRF
Following a meeting in March, the International Medical Device Regulators forum (IMDRF) posted four new documents on unique device identification (UDI) and labeling rules, and four revised documents on standard operating procedures (SOPs), the Table of Contents (ToC) format and adverse events.

01st July 2019

IntraClude Intra-Aortic Occlusion Device Recalled by Edwards Lifesciences
Edwards Lifesciences has recalled the IntraClude Intra-Aortic Occlusion Device with Model number ICF100 and UDI code (01) 00690103190007 after the FDA identified it as Class Ⅰ recall.

01st July 2019

SmartSite Syringe Administration Set recalled by Becton Dickinson
The Becton Dickinson & Company has recalled its SmartSite Syringe Administration Set with the Model number 10798696. The FDA has classified it as Class Ⅰ recall; most serious type of all the recalls.

01st July 2019

Two guidance documents on MDR and IVDR by EC
The European Commission (EC) released two new guidance on MDR/IVDR. One of them is for the persons responsible for regulatory compliance under the Medical Device Registration (MDR) and the in vitro Diagnostic Device Regulation (IVDR) and the another one is on implant card required by MDR.

01st July 2019

Clinicians can ‘See’ Patient Pain using Augmented Reality System
To help clinicians to “see” patient pain in real time, the researchers from the University of Michigan have developed a new system. This new technology has the potential to objectively measure and identify pain in patients who can not communicate their symptoms.

01st July 2019

Mini MRI scanner created by UK scientists to detect knee injuries
For the quick and accurate diagnosis of knee injuries, the researchers from Imperial College London has developed a mini MRI scanner.

01st July 2019

New medical device for tissue pH measurement during surgery
Wideblue, a product design, development and manufacturing consultancy has developed a device for Softcell Medical which is used to measure and display the pH of a patient’s tissue during surgery in real-time.

28th June 2019

BIOMONITOR Ⅲ Injectable Cardiac Monitor Released by BIOTRONIK
BIOTRONIK has decided to upgrade its BIOMONITOR injectable cardiac monitor and is releasing BIOMONITOR Ⅲ to replace BIOMONITOR Ⅱ.

27th June 2019

enFlow Fluid Warming System Disposable Cartridges recalled by Vyaire Medical
Vyaire Medical has initiated the recall of the enFlow Fluid Warming System Disposable Cartridges, Models: 980200EU enFlow - Disposable Cartridge and 980202EU enFlow - Disposable Cartridge with IV Extension Set.

27th June 2019

New guidance for Medical Device Cybersecurity comes into effect in Canada
Health Canada’s new premarket requirements on medical device cybersecurity came into the force, following the adoption of its final guidance draft earlier this month. Under new guidelines, the manufacturers must identify and analyze hazards related to their medical devices to set controls and monitor their effectiveness.

27th June 2019

Health Canada to make medical device adverse event reporting mandatory
Health Canada released new guidelines that will make the reporting of medical device incidents by Canadian hospitals mandatory within 30 days once the regulations come into force. The action was taken to address medical device safety and regulation.

25th June 2019

Scientists developed Bluetooth-enabled medical implant to manage chronic diseases
A new grape-sized Bluetooth implant has been developed by the scientists that can be controlled by a remote to deliver scheduled medication doses. This new device will help the people suffering from chronic diseases like arthritis, diabetes and heart disease to one day forego the daily regimen of pills.

25th June 2019

Transplant’s Vivian device trial showed positive results
The reports from Transplant Biomedicals stated that the Vivian device used in kidney transplantation showed promising interim results in the first human clinical trial.

21st June 2019

Hudson RCI Sheridan and Sheridan Endotracheal Tubes by Teleflex Medical recall: US FDA
Teleflex Medical has initiated Hudson RCI Sheridan and Sheridan Endotracheal Tubes recall. Select Sheridan® branded Endotracheal Tubes and Connectors EIF-000361 and the products with sizes 6.0, 6.5, 7.0, 7.5, 8.0 and 8.5 mm will be recalled.

17th June 2019

Materialise’s cardiovascular planning software gets FDA clearance
The Mimics Enlight cardiovascular planning software suite of Materialise (3D printing solutions company) gets the much-needed green signal from the US FDA. It will help clinicians in patient selection and planning for structural heart and vascular therapy by taking important measurements. It builds on Materialise’s Mimics Innovation Suite, which helps in the generation of patient-specific 3D models.

14th June 2019

Consultation launch to improvise medical devices safety: Health Canada
Ginette Petitpas Taylor, Minister of Health, launched consultations that give Canadian people a chance to comment on proposed changes to protocols that ensure the safety and effectiveness of the medical devices. The life of many Canadians depends on the safety and reliability of medical devices such as insulin pumps, pacemakers.

13th June 2019

US FDA Draft Guidance on Mitigation of Biotin Interference Risk
The US FDA issued a draft guidance for testing biotin interference. This step was taken following a safety communication on an increased risk of adverse events associated with incorrect laboratory test results due to biotin interference.

12th June 2019

Unique identifier issuers for medical devices selected by EU
Four organizations, namely Standards group GS1, the Health Industry Business Communications Council (HIBCC), blood banking association ICCBBA and IFA GmbH (information service provider for pharma market) have been accredited as issuing agencies for the Unique device identifiers (UDIs) in the Official Journal of the EU.

12th June 2019

BIOCORP’s Mallya Device wins CE Ⅱb Approval
The Mallya by BIOCORP has obtained CE 0459 mark as class Ⅱb medical device. BIOCORP founded in 2004 in Issoire, France, is specialized in development and manufacturing of innovative drug delivery systems and medical devices.

11th June 2019

Abbott’s FreeStyle device to reduce glucose levels significantly
The FreeStyle Libre by Abbott is its continuous glucose monitoring (CGM) system which helps in a significant decrease in haemoglobin A1c levels in Type 2 diabetes patients on insulin therapy.

11th June 2019

Heart Failure Management System launched by Zoll Medical
Zoll Medical launched Zoll µCor heart failure and arrhythmia management system (HFAMS). It is a patch-based, non-invasive, wireless system that can be worn for 24 hours a day by patients with fluid management problems. It uses radiofrequencies to track pulmonary fluid levels.

7th June 2019

US FDA grant marketing for first pain relief medical device linked with irritable bowel syndrome
The marketing of first medical device to diminish abdominal pain associated with irritable bowel syndrome (IBS) in patients of 11-18 years age was granted by the US FDA. Innovative health solutions get the green signal to market IB-Stim. It is a safe option where mild nerve stimulation is utilized to treat IBS linked pain in adolescents.

6th June 2019

Continuous glucose monitoring system wins the USFDA approval
The FDA has recently approved a real-time glucose monitoring device developed by Senseonics Inc. The Eversense Continuous Glucose Monitoring System imparts every five minute monitoring for about 90 days to individuals with diabetes.

4th June 2019

Brain stimulation treatment to treat depression
A medical grade, at-home brain stimulation headset launched in UK imparts alternative treatment for depression. It must be utilized along with a therapy app. The Flow has already won the approval for treatment as a Class II medical device in Europe. It is now working with the NHS in order to get it available through prescription.

4th June 2019

USFDA IDE approval wins by Sequana Medical to initiate alfapump Pivotal study
The USFDA has approved Investigational Device Exemption (IDE) application for alfapump (POSEIDON) pivotal study. It will be done in patients with refractory or recurrent ascites due to liver cirrhosis. The positive outcome following the pivotal study would support the approval of alfapump in Canada and the U.S. It would be beneficial for the patients with cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). Less number of study patients and shorter follow-up time to evaluate primary endpoint will be permitted by the final study design.

4th June 2019

Medical device alert by MHRA for Paclitaxel utilization in the UK
The MHRA announced the medical device alert to use paclitaxel in the UK due to its high mortality risk in comparison to associated benefits. One must not utilize drug-eluting stents (DESs) or drug-coated balloons (DCBs) during regular treatment of patients with intermittent claucidation till the further update by the MHRA.

31st May 2019

Agent Unicorn: Boon for ADHD Kids
The Agent Unicorn, which is invented by Anouk Wipprecht, is an interface which can monitor kid’s brain. It contains a fantastic horn along with a headpiece. The horn builds up the interest of kids to play along with imparting medical supervision of their ADHD symptoms. Daily environment monitoring of a kid suffering from ADHD will lead to better diagnosis. The caregivers can modify the environment which is affecting their child’s condition.

28th May 2019

First medical device approved for MPM treatment
The NovoTTF-100L system developed by Novocure Limited receives the USFDA approval. It is the first device which can be utilized along with standard two-drug chemotherapy in patients suffering from a cancerous tumor, malignant pleural mesothelioma (MPM) which cannot be removed through surgery.

23rd May 2019

First diagnostic test to detect Zika virus antibodies: Marketing authorized by the US FDA
InBios International Inc. wins ZIKV Detect 2.0 IgM Capture ELISA marketing authorization from the US FDA. Antibodies produced by the immune system of the body are identified through this kit.

23rd May 2019

Orchid Orthopedia receives US FDA warning letter
Orchid Orthopedia has received the US FDA warning letter for violations such as utilization of unsanitary water for implant cleaning. The company is one of the major manufacturing outsourcers of orthopaedic medical devices.

23rd May 2019

Beckman Coulter blood test analyser recall: FDA alert
The US FDA warns the health care professionals, laboratories and hospitals regarding the utilization of Beckman Coulter blood test analyser. The inaccurate platelet analysis is the reason for its recall.

23rd May 2019

First diagnostic test to detect prosthetic joint infections wins marketing permission by the US FDA
CD Diagnostics Inc. gets the marketing permission for Synovasure Lateral Flow Test Kit from US FDA. This kit can detect the infection related to periprosthetic joint in the synovial fluid. This infection initiates during joint replacement surgery.

22nd May 2019

Loftware’s Enterprise Labeling Solution: Path towards compliance in the Medical Industry
Spectrum for Medical Device is launched today by the global leader in Enterprise Labeling and Artwork Management Solutions, Loftware. It is a digital platform which is exclusively developed to comply the exclusive requirements of device manufacturers. It will also support the manufacturers to cope up with the labelling challenges present in a validated environment. In this manner, it can help the companies to comply with the regulatory requirements such as 21 CFR Part 11, EU MDR, etc.

22nd May 2019

Neuroform Atlas Brain Aneurysms System by Stryker Wins FDA PMA
The premarket approval is granted to the Neuroform Atlas Stent System by the USFDA. This medical device is developed by Stryker to treat brain aneurysms. This approval has been given following the review of efficacy data received through clinical trials.

22nd May 2019

MediSpin XL, advanced electrospinning platform launched by IME for medical devices
MediSpin XL platform is launched by IME, a Dutch medical technology company. This platform will be utilized to manufacture scalable and reproducible fiber-based scaffolds of Class I, II and III medical devices at large scale.

21st May 2019

Boston Scientific Corporation Wins USFDA Approval for VICI Venous Stent System
The USFDA imparts approval to Boston Scientific Corporation for VICI VENOUS STENT system. It can be used to treat narrowed region of iliofemoral vein.

17th May 2019

Warning against unauthorized device utilization to manage diabetes: FDA
The US FDA is cautioning healthcare professionals and patients about the risks linked with utilization of unauthorized or unapproved devices to manage diabetes, such as insulin pumps, continuous glucose monitoring systems and automated insulin dosing systems.

13 May 2019

3D Printed Medical Device: Health Canada issued new guidance
“Technical considerations for non-clinical assessment of medical devices containing nitinol,” is the new draft guidance published by the FDA recently. The proposed recommendation which must be included by the manufacturers during premarket submission of nitinol containing devices is included in this draft guidance. Recommended tests to assess nitinol devices such as biocompatibility, performance under temperature and stresses, and susceptibility to corrosion are also included in the guidance.

24 April 2019

Nitinol-based medical devices: Draft guidance from FDA
“Technical considerations for non-clinical assessment of medical devices containing nitinol,” is the new draft guidance published by the FDA recently. The proposed recommendation which must be included by the manufacturers during premarket submission of nitinol containing devices is included in this draft guidance. Recommended tests to assess nitinol devices such as biocompatibility, performance under temperature and stresses, and susceptibility to corrosion are also included in the guidance.

24 April 2019

Premarket review required to reclassify surgical staplers as Class II devices: FDA
There is a requirement of premarket reviews, performance studies and agency clearance to re-categorize the surgical staplers as higher-risk medical devices by FDA. Surgical staplers are used to stitch tissues together faster in comparison to manual suturing. These have been categorized as Class I-low risk surgical instruments since 1988 for general use.

20 April 2019

First medical device for treatment of ADHD in children approved: FDA
“Technical considerations for non-clinical assessment of medical devices containing nitinol,” is the new draft guidance published by the FDA recently. The proposed recommendation which must be included by the manufacturers during premarket submission of nitinol containing devices is included in this draft guidance. Recommended tests to assess nitinol devices such as biocompatibility, performance under temperature and stresses, and susceptibility to corrosion are also included in the guidance.

19 April 2019

FIRST GENERIC NASAL SPRAY FOR OPIOID OVERDOSE TREATMENT: FDA
The first generic spray, naloxone hydrochloride nasal spray has been approved by the FDA. It is a life-saving medication which is developed to reverse or stop the overdose impact of opioids. It has been stated by the FDA that there will be the development of new steps which can support in prior review of other generic drug applications which can be utilized in the treatment of opioid overdose.

12 April 2019

PoNS device by Helius Medical Technologies gets rejected by US FDA
Premarket submission of Portable Neuromodulation Stimulator (PoNS) device manufactured by Helius Medical Technologies is rejected by US FDA due to insufficient data. This device would be involved in the restoration of neurological function through the delivery of neuromodulation to stimulate cranial nerves.

12 April 2019

FDA warns public not to use Unapproved Medical Devices for detection of Head injuries
The US FDA has warned the public not to use unapproved Medical devices which claim the evaluation, detection or management of head injury such as traumatic brain injury. As per the FDA, they have not reviewed smartphone applications which claim their utilization during sporting injuries.

11 April 2019

Radiofrequency ablation device by Innoblative received FDA approval
The electrosurgical device SIRA RFA by Innoblative Design has received clearance from the US FDA. This has been developed by the company to remove dysfunctional soft tissue with the use of heat generated medium frequency alternating current. This device is claimed to safely facilitate the appropriate removal of clinical targets.

11 April 2019

Reclassification of Medical Device Accessories to Class I by FDA
Eight types of medical device accessories would reclassify to Class I by US FDA. The list of accessories included in final classification involves penile implant surgical accessories, Corneal inlay inserter handle, Biliary stent, drain and dilator accessories, Air-handling apparatus accessory, Suprapubic catheter accessories, Implanted mechanical/hydraulic urinary continence device surgical accessories, Gastroenterology-urology accessories to a biopsy instrument and Ureteral stent accessories.

04 April 2019

Breakthrough Device Designation to COPD system by FDA
Unconditional Investigational Device Exemption (IDE) approval has been received by the company to start pivotal clinical study for the treatment of patients having moderate to severe chronic obstructive pulmonary disease with chronic bronchitis. A Metered Cryospray including liquid nitrogen at -196℃ is utilized in this system to target specific areas within lungs.

02 April 2019

Medical Transfer Adhesive by 3M for Wearable Medical Devices
Extended Wear Medical Transfer Adhesive 4075 has been added by 3M in its innovative list of adhesives developed for wearable medical devices. Imparting patient-friendly adhesive options to design engineers is the major aspect of 3M’s mission. Extended wear pressure sensitive transfer adhesive is the distinguished feature of this adhesive. Exceptional initial skin adhesion for about 14 days depending upon the backing material is offered by this adhesive.

01 April 2019

Market Challenges at Global level for Medical Devices (2019-2025)
The report has been prepared from 2014-2018 and it also includes the prediction from 2019-2025. Country or regional level reports for regions such as UK, Russia, South Korea, United States, China, Japan and India can be seen in report. Cycadia Health, Health Care Originals and Apple are the top companies involved in manufacturing Smart Medical Devices.

25 March 2019

Health Canada gives license to Elekta Unity MR-linac
Magnetic resonance imaging by MR/RT system of Elekta is used to deliver radiotherapy in order to increase cancer treatment. Health Canada has given the license to firm to utilize this system as a Medical Device. The firm can now commercially sale the products. They are now waiting to receive the approval from Canadian Nuclear Safety Commission as well.

23 March 2019

USFDA is investigating the safety of using Breast implants
Breast implants are utilized by several women either to rebuild or enlarge them. These are made up of silicone sacs which are filled with silicone gel or salt water. However, utilization of breast implants is associated with several concerns such as fatigue and debilitating joint pain. This has led to re-examination of its safety by researchers and USFDA.

20 March 2019

Advancement in Medical Devices: Seal verification Technology
A seal verification Technology named as Insura is recently launched by Bemis Healthcare Packaging which has been specifically developed to pack medical devices. This is a non-destructive and real-time visual indicator to determine seal quality rooted into sterile barrier system. If the device is properly sealed, then it can generate blue colour.

20 March 2019

Rapid detection of brain disorder using new dopamine sensor
A rapid dopamine detector has been developed by researchers of University of Central Florida which could assist in detection of brain conditions such as depression and Parkinson’s disorder. These disorders are associated with low levels of chemical dopamine. However, high dopamine levels are associated with several tumors which can be detected using new sensors.

14 March 2019

Valve repair device approval by FDA
The MitraClip Delivery System, a heart valve repair device manufactured by Abbott Vascular Inc. receives FDA approval. The study was conducted on 614 patients who had mitral regulation followed by its approval from FDA. This device can be utilized to treat patients who have developed heart failure symptoms and mitral regurgitation.

14 March 2019

Medical Devices approved by FDA in 2019
Scientists have developed an optical imaging system to detect tiny tumors deep inside the body. This has been developed by MIT researchers in the US and they named it “DOLPHIN”. DOLPHIN relies on NIR light and can trace through 0.1 millimetre fluorescent probe in a living mouse’s digestive tract.

07 March 2019

New optical imaging system to find tiny tumors
Scientists have developed an optical imaging system to detect tiny tumors deep inside the body. This has been developed by MIT researchers in the US and they named it “DOLPHIN”. DOLPHIN relies on NIR light and can trace through 0.1 millimetre fluorescent probe in a living mouse’s digestive tract.

27 February 2019

Questions Answers for EU Medical Devices Regulation
Practical considerations related with medical device implementation along with in vitro diagnostic medical devices regulations are included in Question and Answer document published by European Medicines Agency. This document can impart assistance to applicants regarding the various activities of agency.

18 December 2018

Health Canada issues draft guidance on Premarket device cyber security
In order to help the manufacturers of the medical device in adhering to premarket cyber-security requirement, Health Canada posted new draft guidelines on Friday.

18 December 2018

Sale and distribution of Essure device to be discontinued in US by Bayer
Pharmaceutical company Bayer has decided to stop selling its birth control product Essure in the US after 31st Dec 2018. US FDA imposed restriction on the marketing of the device on Bayer in April this year due to inadequate risk information and other requirements to ensure the device’s safety and effectiveness. However according to Bayer,”

18 December 2018

Pre-market approval by FDA given to Strykers flow diverter
A Stryker is a medical technology company which has obtained pre-marketing approval from USFDA for the use of its Surpass Streamline Flow Diverter in treating unruptured large and giant wide-neck intracranial aneurysms. Surpass Streamline is already marketed in other international countries and is the second such device to get USFDA approval.

18 December 2018

Surgical Guidance Firm Endomag has received USFDA approval for breast cancer device called Magtrace
Pre-market USFDA approval has been granted to Magtrace, the first non-radioactive dual-tracer device for lymphatic mapping in breast cancer patients manufactured by Surgical guidance firm Endomag. Currently breast cancer is treated through surgical removal of tumor and then a lymphatic mapping procedure to determine whether or not the cancer has spread to other parts of the body which usually involves the use of radioactive drugs and blue dyes having limited availability.

18 December 2018

AstraZeneca collaborates with Geisinger to develop an app for Asthma care
Pre-market USFDA approval has been granted to Magtrace, the first non-radioactive dual-tracer device for lymphatic mapping in breast cancer patients manufactured by Surgical guidance firm Endomag.

18 December 2018

USFDA approval given to Medtronics less invasive approach to implant LVAD
Medtronic is a global medical device company based in Dublin, Ireland providing medical technology, services and solutions. The company has received USFDA approval for its less invasive implantation procedure of the left ventricular assist device (LVAD) called HeartWare HVAD system. This will be helpful in cases of advanced, refractory hear failure patients.

13 July 2018

510(k) clearance to medical device company Embolx's pressure-directed arterial embolisation system granted by USFDA
The embolisation therapy facilitates the delivery of drugs and embolic agents to the targeted treatment areas thereby protecting the surrounding healthy tissues.

13 July 2018

USFDA approval given to Zephyr Endobronchial Valve System developed by Pulmonx
Zephyr Endobronchial Valve System has been designed by Pulmonx (an interventional pulmonology treatment provider) to treat severe emphysema, a type of chronic obstructive pulmonary disease (COPD).

13 July 2018

iStent inject Trabecular Micro-Bypass System developed by Ophthalmic medical technology company Glaukos received FDA approval
Glaukos is an Ophthalmic medical technology company which has got the US Food and Drug Administration (FDA) premarket approval (PMA) for its iStent inject Trabecular Micro-Bypass System for the use of the system to decrease intraocular pressure (IOP) in adults with mild-to-moderate primary open-angle glaucoma (POAG) and undergoing concomitant cataract surgery.

13 July 2018

USFDA approval given to Eversense Continuous Glucose Monitoring (CGM) System of Senseonics
Premarket Approval (PMA) application by USFDA has been granted to Senseonics Holding's Eversense Continuous Glucose Monitoring (CGM) System which is designed for diabetes patients. According to the company’s president and CEO Tim Goodnow," The FDA approval will allow to make Eversense available in the US, as it is available already in many European markets."

13 July 2018

Improvement in atrial fibrillation diagnosis observed with the use of home based ECG patch
In almost 20% of individuals experiencing a stroke due to AFib, the occurrence of AFib is not diagnosed until the time of their stroke or shortly afterward. However if AFib can be recognized early then there can be an absolute risk reduction in all strokes of 2.7% per year for primary and 8.4% per year for secondary prevention, as well as a 0.5% per year absolute risk reduction in mortality.

14 June 2018

Regulation-on-ultrasound-machine-and-other-imaging-machines-to-be-made-more-strict-by-the-government-of-India
It has been decided by the government of India to make the regulations more strict for ultrasound machines and other imaging equipments to prevent import of these equipments without proper registration.

14 June 2018

New medical device guidelines to contribute to 25-50% of the cost of medical devices procured by the government
According to the proposal by the Department of Pharmaceuticals, domestically sourced components have to contribute to 25-50% of the cost of medical devices procured by the government.

14 June 2018

Optovue's OCTA blood vessel measurement technology approved by USFDA
510(k) clearance from the US Food and Drug Administration (FDA) has been given to the AngioAnalytics, world’s first optical coherence tomography angiography (OCTA) blood vessel measurement technology to firm Optovue.

14 June 2018

A new minimally invasive medical device called Therepi developed to deliver medicine directly to heart
A team of researchers including researchers from Harvard University and Massachusetts Institute of Technology (MIT) and National University of Ireland (NUI) Galway have developed a new minimally invasive medical device called Therepi that can be sutured onto diseased heart tissue to continuously deliver required drugs, proteins or stem cells.

14 June 2018

New test system launched by Abbott in US for management of Diabetes.
New Afinion 2 analyser ,a rapid multi-assay platform to provide optimized and simplified results that are accurate and actionable at point-of-care has been launched in US by Abbott for Diabetes management.

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