Oura Lobbies for Looser FDA Regulations, Benefiting Apple Watch

Wearable device maker Oura is pushing for a new "digital health screener" category to avoid strict medical device rules.

Published on Feb. 9, 2026

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Smart ring maker Oura has significantly increased its lobbying efforts in Washington, D.C. in 2025, spending over $1 million to convince U.S. lawmakers to create a new regulatory category for wearable devices that would allow them to bypass the strict medical device approval process required by the FDA. If successful, this could directly benefit Apple's Apple Watch by enabling faster rollout of health-tracking features like non-invasive glucose monitoring.

Why it matters

Oura's push for looser regulations aims to spur innovation in the wearables industry, but it also introduces potential risks if devices provide inaccurate health data that could lead users to make dangerous decisions about their health. The FDA's strict review process is intended to ensure the reliability and safety of health-monitoring features, so bypassing it could have serious consequences for consumers.

The details

Oura has increased its lobbying budget from $40,000 in 2024 to over $1 million in 2025 as it works to convince Congress and the FDA to create a new "digital health screener" category for wearable devices. This would allow them to bypass the lengthy and rigorous medical device approval process. Oura CEO Tom Hale has argued that wearables should be able to warn users to seek medical attention without being classified as full-fledged medical devices. The FDA has already made some changes along these lines, but Oura is pushing for further legislative action.

  • Oura spent just $40,000 on lobbying in 2024.
  • Oura's lobbying budget exceeded $1 million in 2025.

The players

Oura

A Finnish smart ring maker that is the market leader in the wearable device industry. Oura has significantly increased its lobbying efforts in Washington, D.C. in an attempt to convince lawmakers to create a new regulatory category for wearable devices.

Tom Hale

The chief executive officer of Oura, who has written op-eds calling for the FDA and Congress to create an exemption for wearable devices to avoid the "medical grade" classification.

Rep. Troy Balderson

A Republican congressman from Ohio who is the chair of the House digital health caucus and is working on legislation to create an environment for wearables to expand and be more innovative.

Alex Vannoni

The VP of healthcare at Whoop, a rival wearables maker, who has urged "caution" when considering the creation of an unregulated and undefined "digital health screener" category for wearable devices.

Apple

The tech giant that produces the Apple Watch, which could directly benefit from any changes to FDA regulations that make it easier to roll out new health-tracking features like non-invasive glucose monitoring.

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What they’re saying

“We must not let individuals continue to damage private property in San Francisco.”

— Robert Jenkins, San Francisco resident (San Francisco Chronicle)

“Fifty years is such an accomplishment in San Francisco, especially with the way the city has changed over the years.”

— Gordon Edgar, grocery employee (Instagram)

What’s next

The judge in the case will decide on Tuesday whether or not to allow Walker Reed Quinn out on bail.

The takeaway

This case highlights growing concerns in the community about repeat offenders released on bail, raising questions about bail reform, public safety on SF streets, and if any special laws to govern autonomous vehicles in residential and commercial areas.