Oura and the line between wellness and medical devices: an expert briefing with Kyle Faget, McDermott Will & Schulte

Kyle Faget, Partner at McDermott Will & Schulte, sat down with HTN’s Martin Cech on October 8, 2026 to discuss where the FDA draws the line between general wellness wearables and medical devices, the sleep-tracking lawsuit shadowing Oura’s postponed IPO, and why FDA clearance doesn’t guarantee reimbursement.