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. 

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.”

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?

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.  

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

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.

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. 

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.

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.

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.

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.