How Fitbit and Apple Are Battling for the Medical Device Registers episode artwork

EPISODE · Jun 3, 2026 · 15 MIN

How Fitbit and Apple Are Battling for the Medical Device Registers

from The Digital Health Podcast with Fexingo: Wearables, Diagnostics, and Health Software · host Fexingo

Lucas and Luna dig into an escalating regulatory war that most consumers don't even know exists. Fitbit's new sleep apnea detection feature got FDA clearance in March 2026, and Apple's atrial fibrillation algorithm now powers a multi-center clinical trial enrolling 15,000 patients. But behind the headlines, both companies are waging a quiet battle over something much bigger: who gets to own the FDA-cleared claim for 'passive health screening' on a wrist-worn device. Lucas walks through the specific filings, the timing, and the commercial stakes — including why Medicare reimbursement is the real prize. Luna brings up the tension between algorithmic transparency and proprietary hardware, and asks whether either company's data is actually good enough for a doctor to act on. The episode pulls back the curtain on a defensive land grab that will determine how your smartwatch talks to your doctor by 2028. #Fitbit #Apple #Wearables #FDA #SleepApnea #AFib #MedTech #ClinicalTrial #HealthRegulation #Algorithm #Reimbursement #DigitalHealth #PassiveScreening #WristWorn #Business #Technology #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo

Episode metadata supplied by the publisher feed · Published Jun 3, 2026

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How Fitbit and Apple Are Battling for the Medical Device Registers

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This episode was published on June 3, 2026.

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