Dive Brief:

Movano Health received 510(k) clearance for the pulse oximeter feature in its Eviemed smart ring, the company said Monday.

The Food and Drug Administration clearance advances Movano’s plans to market the wearable device to organizations that run clinical trials and healthcare companies that are helping patients manage chronic diseases.

Movano secured the clearance on the strength of two trials that compared the accuracy of its technology to traditional pulse oximeters such as the Masimo Radical-7 and Nellcor N-595.

Dive Insight:

Movano launched the Evie Ring as a general wellness device without any FDA premarket clearances. In the general wellness space, Movano competes with companies such as smart ring manufacturer Ōura, which recently received a $75 million investment from Dexcom. Movano has identified FDA clearance of its smart ring as a way to differentiate its technology and unlock the market for clinical-grade devices.

Having withdrawn its first 510(k) filing in 2023, Movano resubmitted this year using data from a second trial of its ring. Movano CEO John Mastrototaro said on an earnings call in November that the FDA “came back with a lot of the questions related to the medical device aspects of the product.”

The questions delayed the process, which Movano had expected to complete by July, but the responses led the FDA to clear the device late last week. Movano began re-engaging with potential customers in the run up to the FDA decision, Mastrototaro said, and was focused on three strategic partners at the time of its earnings call last month.

Mastrototaro said Movano was in “active discussions with a major global pharmaceutical company looking to leverage Eviemed in building unique solutions for both clinical and consumer applications.” The company was also talking to a clinical research organization that was considering adding the ring to the service it offers biopharma companies.  

Movano called the third potential partner a large payor in the announcement of the 510(k) clearance. The company said it is in “the agreement phase” for a pilot study that is slated to start early in 2025. The payor is considering using the ring “as part of an overall metabolic solution to address chronic disease,” Mastrototaro said.

The clearance comes as patients and the medical device industry are focused on racial bias in pulse oximeters. Studies have shown pulse oximeters can overestimate oxygen saturation in people with dark skin pigmentation.

The FDA prioritized draft guidance on pulse oximeters for its fiscal year 2024, covering performance testing, labeling and premarket submission requirements. However, the agency missed the deadline and listed the draft guidance as a priority for its fiscal year 2025, which began in October.

A trial showed that Movano’s Eviemed ring exceeds the FDA blood oxygen accuracy requirement. Movano claimed in the Monday press release that the device produces accurate readings in users with darker skin tones.

Movano has identified FDA-grade accuracy and a wearable design that may be more comfortable than fingertip-based monitors as a combination that could support remote monitoring. The company ended September with $11.3 million in cash and cash equivalents and reported an operating loss of $7.4 million in the third quarter.