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Biologics Boss: FDA Looking For Alternative Medical Device Sourcing Due To COVID-19

Peter Marks, head of the US FDA’s biologics center, says the agency is looking for alternative sourcing and manufacturing of medical products imported from China, including medical devices, to ward off potential shortages that could result from the ongoing coronavirus crisis and containment.

Infectious Diseases Manufacturing China

FDA Recommends Further Limiting Use Of Laparoscopic Power Morcellation

The US FDA is updating its labeling guidance on laparoscopic power morcellation to reflect new evidence showing the treatment may pose a higher cancer risk in older women, as well as to add discussion of containment systems.

Gynecology & Urology Guidance Documents FDA

Apple And J&J Collaborate On Large Atrial Fibrillation Study

The Heartline Study is evaluating how the Apple Watch can identify and predict atrial fibrillation while improving cardiovascular outcomes and patients’ adherence to anticoagulant drugs.

Clinical Trials Digital Health Research & Development

Lucky STAR: FDA’s eSTAR Pilot Aims To Make 510(k) Process Smoother

Nine device makers will soon have the chance to enroll in a voluntary eSTAR pilot program that the US agency says will make the premarket review process more efficient and consistent. The design and structure of an electronic Submission Template And Resource – or eSTAR – template is similar to templates used by FDA reviewers. An eSTAR won’t change the agency’s statutory or data requirements for sponsors to show substantial equivalence to predicate devices.

FDA Review Pathway Policy

Spotlight On Coronavirus

EU Calls For COVID-19 Diagnostic Research Projects

As fears grow that a full-blown COVID-19 pandemic may be on the way, a European public-private consortium is to make available a total of €45m (US$49m) in funding for projects aimed at accelerating the development of diagnostics and therapeutics to help tackle the current outbreak and any future coronavirus threats. 

Europe Diagnostics

Back With A Bang: ‘Brexit Bill’ For UK’s Medical Devices Due For 2nd Reading On 2 March

Parliamentary debate next week on the post-Brexit regulatory adjustments ahead for the UK medical devices industry will coincide with the opening of post-Brexit EU trade talks by the UK government. After a period of nervous calm, Brexit will be back with a bang.

United Kingdom EU Regulation

QUOTED. 26 February 2020. Mark Leahey.

In an exclusive interview with Medtech Insight, Mark Leahey, president of the Medical Device Manufacturers Association (MDMA), said the previous four Medical Device User Fee negotiations with the US FDA have set a strong foundation for the industry and the next round of negotiations should focus on tweaking past deals that are already in place. See what MDMA's president, Mark Leahey, said about it here.

Quoted Regulation Reimbursement

Countdown to EU MDR

 
The EU Medical Device Regulation comes into force on 26 May. Click here to read more.
 

Latest from PR Newswire

Click here to access further medical device and diagnostics news.
 


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Medtech IT: How To Stay Ahead As Technology Accelerates

Outdated medtech IT solutions are stopping people from efficiently performing their jobs, a survey has found. Read this whitepaper to view more survey results and discusses how tech is changing Medtech.

Read the Whitepaper

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Top Lobbyist: User Fee Deal Should Focus On Agreements Already In Place

In an exclusive and wide-ranging interview with Medtech Insight, Mark Leahey, president of the Medical Device Manufacturers Association, said the previous four Medical Device User Fee negotiations with the FDA have set a strong foundation for the industry and the next round of negotiations should focus on tweaking past deals that are already in place.

Regulation Lobbying Reimbursement

Brazil Levels Medtech ICT Tariffs Playing Field

All medtech in Brazil will soon be subject to standardized industrial tariffs and development-related fiscal incentives, following a reform of rules relating to ICT across all industries.

Policy Brazil Medical Device

EU Calls For COVID-19 Diagnostic Research Projects

As fears grow that a full-blown COVID-19 pandemic may be on the way, a European public-private consortium is to make available a total of €45m (US$49m) in funding for projects aimed at accelerating the development of diagnostics and therapeutics to help tackle the current outbreak and any future coronavirus threats. 

Europe Diagnostics

Hunt On For New Chair Of UK Regulator

Whoever takes over as chair of the Medicines and Healthcare products Regulatory Agency will play a key role in its plans to deliver a program of “ambitious business change.”

United Kingdom Brexit

Switzerland And UK Work On Closer Medtech Ties As EU Links Fall Apart

Switzerland’s current economic and trading relationship with the UK is based on its MRA with the EU. So, where does this leave the two countries in trading with one another now each of their relationships with the EU are under threat?

Switzerland United Kingdom

QUOTED. 24 February 2020. Daniel Taddeo.

Political tensions between Switzerland and the EU have led to concerns about the future status of the only Swiss medtech notified body, SQS. Here’s what SQS board member Daniel Taddeo said about the situation.

Quoted Switzerland

Class I Recall On Abbott Coronary Catheters

The US FDA has announced a high-risk class I recall on two makes of coronary dilation catheters made by Abbott Vascular because a manufacturing issue could lead to difficulties deflating the balloon. The catheters have been linked to 13 complaints and one death.

Recalls Safety

Device Week, 20 February 2020 – Industry Concerns Grow As Clock Is Running Out On EU MDR

With fewer than a hundred days left before the EU Medical Device Regulations kick in, Medtech Insight’s executive editor Ashley Yeo and managing editor Amanda Maxwell discuss in this week's podcast growing concerns by medtech industry members that they may not be ready in time to comply with the regulations and may inadvertently run afoul of them.

Device Week Regulation

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Top FDA Officials: Agency Actively Cracking Down On Medical Products With Sham COVID-19 Claims

US FDA commissioner Stephen Hahn and ORA associate commissioner for regulatory affairs Judith McMeekin said in a joint 24 February statement that the agency continues to aggressively monitor the market for firms selling products with fraudulent COVID-19 prevention and treatment claims. The officials also explained that the FDA has the authority under FDASIA to ask for records from drug manufacturers in lieu of conducting facility inspections. It can't do the same for device companies, however, because no similar provision exists. The FDA had announced on 14 February that it paused all inspections of Chinese manufacturing facilities in the near-term.

Infectious Diseases FDA

Philips Expert Urges Device Makers: Update Quality Systems To Conform To Revised Risk Standard ISO 14971

It’s time for manufacturers to begin adopting the new 2019 version of ISO 14971, the international standard for risk management widely used by industry. But firms need to do more work than just changing the date on risk-related procedures and documents to “2019,” says Jos Van Vroonhoven, a senior manager at Philips Healthcare who was intimately involved with the standard’s redo. From conducting gap assessments to creating cross-functional teams, both Van Vroonhoven and longtime industry expert Don Powers tell Medtech Insight how firms can keep their quality systems up-to-date to conform to ISO 14971:2019.

Risk Management Standards

Crosswalk: ISO 14971:2007 Vs. ISO 14971:2019

Here’s a crosswalk for recently revised international risk management standard ISO 14971 and its 2007 predecessor.

Risk Management Standards

Commercial Explore this Topic

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Cardiovascular Sales & Earnings Roundup: Medtronic TAVR Disappoints While Abbott And Boston Scientific See Structural Success In 2019

The top five cardiovascular device companies, as ranked by Medtech Insight’s MTI 100, have reported their sales and earnings for the last quarter of the calendar year 2019. Here are the highlights from the most recent presentations from Medtronic, Abbott Laboratories, Boston Scientific, Edwards Lifesciences and Terumo.

Commercial Sales & Earnings Companies

Execs On The Move: Conformis And EyeKor Make Major Management Changes

Knee implant manufacturer Conformis Inc. brings aboard new chief financial officer/treasurer and operations SVP; imaging and data management software company EyeKor promoted its president/CTO to CEO; and more.

Commercial Appointments

Start-Up Spotlight: 'Cheeky Tech' – How Binah.Ai Uses Math, Plethysmography And AI To Extract Vital Signs From A Person's Cheeks

Israel-based start-up Binah.ai plans to file for US FDA approval of its video-based monitoring app that can detect vital signs in seconds with a simple scan of a person's cheeks.

Start-up Spotlight StartUps and SMEs

Start-Up Snapshot: Barcode Diagnostics, Personalized Cancer Drug Screening

Barcode Diagnostics is developing a nanotechnology for personalized cancer drug screening. The start-up’s aim is to provide physicians with a tool that matches patients with the most effective medicine, during the different stages of disease.

Israel Innovation

Castor’s Data Platform Will Make Medical Research More Efficient

Dutch data-capture company Castor is aiming to make the world’s medical research data reusable. The cloud-based platform enables medical device companies to capture, process and integrate data from multiple sources on a centralized platform.

Real-World Evidence Research and Development Strategies

Start-Up Snapshot: CorNeat Vision’s Implantable Artificial Cornea

Ophthalmic start-up CorNeat Vision is entering a multi-center clinical trial for its artificial cornea device CorNeat KPro. The implant uses advanced cell technology to biomimic the cellular structure of the eye and integrate with tissue. Medtech Insight met with CorNeat's CEO, Almog Aley-raz and CMO, Gilad Litvin at the OurCrowd Global Investor in Jerusalem, February 13, to hear more.  

Israel Innovation

European Debut For CMR Surgical’s Versius Surgical Robot In Two UK NHS Hospitals

CMR Surgical’s Versius robotic system is now live in the UK NHS, the company announced 20 February.

United Kingdom Robotic Surgery

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

New Real-World Data Show Benefits Of Abbott's FreeStyle Libre Technology

New real-world data, presented at a recent diabetes conference in Madrid, showed that Abbott's FreeStyle Libre system provided several clinical benefits for patients with diabetes.

Clinical Trials Diabetic Care Research & Development

Grail Starts PATHFINDER Trial To Evaluate Multi-Cancer Blood Test For Early Cancer Detection

Grail announced it will enroll about 6,200 people in an interventional, multi-center study evaluating its multi-cancer early-detection blood test. This is the first time health care providers will use this test to help guide patient care.

In Vitro Diagnostics Cancer

QUOTED. 13 February 2020. Charles Cadieu.

The US FDA cleared Caption Health's Caption Guidance software, an AI package that guides users through cardiac ultrasounds to help them capture the best images. See what Caption Health's co-founder and president, Charles Cadieu, said about it here. 

Quoted Approvals

Newly Cleared Cardiac Ultrasound Software Could Broaden Imaging User Base

The US FDA has cleared Caption Guidance software, an AI package that guides users through cardiac ultrasounds to help them capture the best images. In clinical trials, the system allowed untrained nurses to gather diagnostic-quality pictures and videos.

Diagnostic Imaging Approvals

Medtronic Hopes To Refine Renal Denervation Hypertension Therapy With New Trial

The 50-patient SPYRAL DYSTAL trial will evaluate the benefits of a new targeted renal denervation approach with the Symplicity Spyral renal denervation system in patients with uncontrolled hypertension.

Clinical Trials Innovation

Italian Medtech Industry Launches Investment Trends Study

The Italian medtech industry association Confindustria Dispositivi Medici has launched a major survey of the activities and investment strategies of the sector’s almost 4,000 domestic developers and manufacturers.

Italy Medical Device

Abbott Stays Ahead Of Edwards In Transcatheter Mitral Valve Race With Tendyne CE Mark

Tendyne is indicated for the treatment of significant mitral regurgitation in patients who are not candidates for surgery. It complements Abbott’s MitraClip mitral valve repair device and is an important part of the company’s strategy to be the leading structural heart device company.

Approvals Clinical Trials
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