Kyle Faget discusses the line between wellness wearables and medical devices in expert briefing with Health Tech Nerds

In a recent expert briefing with Health Tech Nerds’ Martin Cech, Kyle Faget discusses where the FDA draws the line between general wellness wearables and regulated medical devices, using Oura as a case study.

The conversation also covers the sleep-tracking lawsuit shadowing Oura’s postponed IPO, and why FDA clearance for a device doesn’t guarantee reimbursement.