New FDA Guidance Comment Published in Nature BME

Please check out our lab’s latest publication in Nature Biomedical Engineering: “Unaddressed implications of the FDA’s 2026 guidance on wellness devices”!

As consumer wearables increasingly measure health-related signals, the line between “wellness” products and medical devices is becoming harder to define. In this comment, we examine the FDA’s 2026 wellness device guidance and discuss important unanswered questions regarding device validation, safety, regulatory definitions, and the integration of wearable data into healthcare.

The key takeaway: fostering innovation in digital health is important, but we also need clear standards to ensure wearable technologies are trustworthy, safe, and clinically meaningful as their role in healthcare grows.

Congratulations to the authors: Stephanie Sullivan, Anita Shlesinger, Karnika Singh, Perisa Ashar, and Dr. Jessilyn Dunn!