Medtech Insight - News And Expert Analysis For Medtech Decision Makers since 1975

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.

Maria Shepherd, co-founder of MedExec Women, a nonprofit that seeks to empower executive leaders in medtech, is preparing to host the group’s fifth annual conference in Boston, which is expected to draw 200 attendees. Shepherd spent more than two decades in the medical device industry before starting consulting firm Medi-Vantage. She talks to Medtech Insight about her own career path, how the industry is changing, and the importance of “grooming” the next generation of young medtech leaders.

Exec Chat: Dexcom’s COO Jake Leach joined a panel discussion on the future of biosensing at CES 2024, where biowearables and glucose tech ranked among hot topics. He also spoke to Medtech Insight about plans for the company’s new CGM called Stelo, designed for people with type 2 diabetes who do not use insulin, Dexcom’s work with Apple to enable CGM users, and non-invasive monitoring prospects.

Despite challenges and projected European decline, the in vitro diagnostics market has enticing "pockets for growth" post-pandemic, industry leaders revealed at the MedTech Forum conference. Key drivers include healthcare decentralization and consumer pull for control over health. Opportunities exist in neurology, oncology, and direct-to-consumer testing.

AI and generative AI ruled much of the discussion at HLTH Europe 2024. A panel of health care leaders from Microsoft, Philips, insitro and Johnson & Johnson discussed how these new technologies are already transforming health care and pointed to risks and challenges.

AI is all the rage these days, so it comes as no surprise that the topic of AI technologies ranked high during the panel discussions at the HLTH Europe event, held from 17-20 June in Amsterdam.