Digital Health

This week, Change Healthcare admittedi ts February breach revealed sensitive information like medical diagnoses and Social Security Numbers; the Coalition for Health Artificial Intelligence released its Assurance Standards Guide and Reporting Checklist for developers; and the FDA announced public meetings in July on IVD classification, the Home as a Health Care Hub initiative, and device sterilization.

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.

Vijay Ravindran, founder of autism therapy digital therapeutic firm Floreo, spoke to Medtech Insight about working with the FDA, and why the TAP pilot made sense for them.

Andrew Trister, Verily’s chief medical and scientific officer, spoke with Medtech Insight at the HLTH Europe conference about Verily’s newly launched Lightpath Metabolic solution, featuring GLP-1 prescription, AI and strengthened clinical support. Trister also talked about plans for the Study Watch and offered views on the Alzheimer’s research landscape and AI development and regulation in a new era of uncertainty.

This week, Boston Scientific agreed to pay $1B+ for stroke prevention device firm Silk Road Medical; the FDA asked for feedback on patient safety for non-device medical software; and a former medtech CEO was sentenced to six years for her part in a phony device scheme.

Cutting edge technology could significantly enhance operating room efficiency, according to a new report from Medtronic. The problem, however, is that most ORs don’t have it.

Leading digital therapeutic maker’s CEO David Benshoof Klein and CMO Shaheen Lakhan discuss outlook on the DTx space, priorities going forward, and what makes Click a standout player in a changing game.

The digital therapeutics community has identified unique revenue streams, friendly regulations and development opportunities that have them feeling optimistic.

This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.  

The principles urge device makers to look at the whos, whys and whats of device use in developing their data transparency approaches.

Digital therapeutics aren’t going away anytime soon, but they are positioning themselves as a complement to traditional therapies.

Medtech Insight talked to two leaders at the Alzheimer’s Drug Discovery Foundation about current therapies and the role of biomarkers and digital tools to build on recent advancements in the space and accelerate progress to identify the disease early and slow cognitive decline.

In an interview with Medtech Insight sister publication the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

The Digital Therapeutics Alliance’s annual summit kicked off in Washington, DC, with a robust panel schedule that included advice on reimbursement strategies, provider access, and lessons learned from past mistakes.

The France-based, clinical-stage medtech has enrolled first patients in a pivotal trial to evaluate overall survival in glioblastoma patients using its implanted SonoCloud-9 ultrasound device combined with a chemotherapy. If successful, it will become the first technology to optimize drug delivery by opening the blood-brain barrier.