Executive Exclusives

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

The Swedish company has developed a proprietary method of personalizing venous grafts, and plans to bring it – alongside some other products – to the market.

Lifespin is working on tools to characterize a patient’s metabolism and provide more detailed information about a disease.

Ken Block of Ken Block Consulting weighs in on the FDA’s Breakthrough Devices Program, its implications for raising capital, achieving speedier market access, and inviting more intensive regulatory scrutiny in this interview with Medtech Insight.

In this episode, Medtech Insight regulatory reporter Hannah Daniel and managing editor Amanda Maxwell speak to Marcel Gehrung, co-founder and CEO of Cyted. Marcel discussed global regulations for Cyted’s product Endosign, and how the company leveraged the product’s flexibility to gain approval and reach markets as efficiently as possible. We also talk about different market authorization requirements in the EU, UK, and US, and the use of AI in healthcare spaces in the UK.

The seasoned regulatory attorney, who recently moved to law firm King & Spalding, spoke to Medtech Insight about his priorities, what keeps him interested in device law, and the three things manufacturers should consider when seeking a device approval.

Medtech Insight followed up with Invitae’s Deven McGraw about further possible confusion that could be caused by the Federal Trade Commission’s proposed amendments to the Health Breach Notification Requirements (HBNR).

Israeli-based medtech company GaitBetter is hoping to make bigger strides in bringing its VR- and AI-based gait training and rehabilitation solution to more physical therapy clinics in the US.

Significant financial reward awaits drugmakers that invest more in companion diagnostics during the development and marketing of precision cancer drugs, says Peter Keeling, CEO of Diaceutics – but Novartis warns that relying on pharma firms to fund these tests is unsustainable.

GLP-1 inhibitors for weight loss are rapidly threatening several medtech segments; however, in ensuring their long-term efficacy, digital health companies could benefit.

The European medical device database, Eudamed, is arguably the missing lynchpin in the implementation of the EU’s Medical Device and IVD Regulations. Medtech Insight spoke with Lionel Tussau of atrify to discover what companies need to know now and how actors should be preparing.

Robet Steinbrook, the third director of the 50-year-old health group, plans to stay true to the organization’s long-held mission of holding FDA approvals to high standards, pushing for stronger evidence of benefit, more attention to safety, and advisory committee votes.

In this episode of Medtech Connect, EU Senior Reporter Eliza Slawther and US Reporter Hannah Daniel explore the similarities and differences between EU and US regulations for digital health products in this mid-season recap episode. We talk about cybersecurity legislation, reimbursement of digital health products, and current AI regulations. If you are looking for a bird’s eye view of regulations in these two places, this is the episode for you.

Orthopedics Corner is a new series highlighting new developments in spine and orthopedics technology you may have missed. Catalyst OrthoScience CEO Carl O’Connell, along with surgeon and researcher Matthew Budge, talked to Medtech Insight about Catalyst’s innovation in shoulder arthroplasty.

In the EU, the amending regulation to the MDR is not creating as many waves as the amending regulation to the IVDR did. The reasons are many.  But this is good news for the medtech industry, as is a general uptick in purposeful communication.

Thermal imaging technology has existed for almost 100 years, but still has plenty of untapped power in medical diagnostics. Finnish healthtech Thermidas explains why its AI-assisted thermal imaging software is a potential game-changer for people with diabetes.