Smart ring maker Oura is lobbying U.S. lawmakers to loosen FDA regulations on wearable health monitoring devices, a move that could significantly benefit Apple's health-focused products like the Apple Watch. The Finnish company has dramatically increased its lobbying budget from $40,000 in 2024 to over $1 million in 2025, seeking to create a new "digital health screener" category that would exempt wearables from medical device classification.

Currently, the FDA regulates wearables as either general wellness products with minimal oversight or as medical devices requiring extensive safety reviews. Oura CEO Tom Hale has argued for a third category that would allow devices to warn users about potential health issues without making diagnoses. The FDA has already made some rule changes in response, allowing wearables to suggest users seek medical evaluation and enabling blood pressure and blood sugar monitoring without full medical device approval.

This regulatory shift could accelerate Apple's development of features like non-invasive glucose monitoring, which the company has been researching for years but has yet to implement due to FDA constraints. While reduced oversight could speed innovation and bring new health features to market faster, experts warn it also introduces risks. Inaccurate health readings could lead users to make dangerous medical decisions, as evidenced by faulty glucose monitors linked to deaths and injuries. The debate highlights the tension between innovation and safety in consumer health technology.

Quick Fact: Oura increased its lobbying budget from $40,000 in 2024 to over $1 million in 2025.