Digital Health

In this wide-ranging interview, lawyer Philip Desjardins talks about regulatory issues from AI to LDTs – as well as the passion for patient health that keeps him in the medtech arena.

The American Medical Association has written a set of principles for augmented intelligence (AI) development and deployment in health care. The organization hopes these principles can shape “a consistent governance structure for advancements in health care technology.”

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with Abbott’s head of Lingo Biowearables and top executives at Twin Health. Reed Miller provides an update on J&J MedTech’s launch of the Ottava soft-tissue robotic surgery system and Barnaby Pickering talks about his recent interview with Leo Grady, former CEO of Paige AI, to talk about his new start-up Jona.

The DTx company’s revenue grew some 500% to $702,000 in the fiscal 2023 third quarter, reflecting its direct-to-consumer launch of EndeavorOTC to adult ADHD patients in June under a US FDA enforcement policy established for digital health devices during the COVID-19 public health emergency. That policy has since sunset, and Akili has submitted a 510(k) application to the agency for review.

Experts lamented the lack of consensus standards for AI medical devices, which they said could pose harm to innovators.

Medtech Insight spoke with chief AI officer for Medtronic's Endoscopy unit, Ha Hong, about his vision for integrating AI technologies into medical devices, the challenges and benefits of using AI, the importance of responsible use of AI, generative AI and the role of AI in the future of health care.

 Stakeholders discussed the need for transparency and explainability of AI models at the AI Summit in Cincinnati. 

In this podcast, Medtech Insight speaks to Andy Molnar, CEO of the digital therapeutics alliance; Joel Morse, CEO and co-founder of Curavit and Owen McCarthy, CEO and co-founder of MedRhythms. The trio discuss the current situation surrounding digital therapeutics, and where they believe they are headed in the coming years.

In 2024, Visana Health will leverage $10.1m in seed funding to expand its holistic, value-based virtual clinic to add conditions that differently or disproportionally affect women and provide at-home testing. Health plans and employers are taking notice, and Visana’s CEO expects further investment to follow.

Getting out the gates early is usually the playbook for VC, however when it comes to new technologies with untested commercial pipelines, waiting and seeing may be a smarter approach.

Women’s health start-ups focusing on areas of high unmet need such as menopause, infertility, preventive care and post-partum care will continue to attract investors, experts say. Meanwhile, machine learning and AI, as well as next gen-treatments such as psychedelic therapy, stand to drive advancements in the space.

UK ministers are increasingly focusing on the need to improve uptake of new technologies in the National Health Service. Ambitious programs have been launched but implementing them effectively for lasting change in a delivery system under acute stress is a challenge of a different order.

This week, the US FDA announced that several pandemic-era guidance documents are no longer in effect; an FDA advisory committee meeting on multi-cancer detection (MCD) diagnostics was scheduled; and both a needle-free blood collection device and the first VR treatment for pain and anxiety landed FDA clearances.

Amazon announced it will offer Prime members a One Medical subscription for $9 a month, or $99 a year in a move to “make it easier for people to get the health care they need.”

Some of the industry news from last week that Medtech Insight is tracking: The FDA granted its breakthrough status to Toku's Clair AI technology for finding markers of cardiovascular disease in retinal scans. Dupont is partnering with STMicroelectronics on a new patch sensor technology, ReWalk secures Medicare coverage for its exoskeleton, and more.

This week, 25 state attorneys general pressed FDA Commissioner Robert Califf to improve pulse oximeter safety warnings; MDIC extended the deadline on an industry cybersecurity benchmark study; and more guilty pleas and settlements were entered in Medicare fraud cases.