Movano has got FDA-clearance for the pulse oximitary sensor in its EvieMED smart ring.
Movano has received FDA clearance for the pulse oximetry in its EvieMED ring, opening the door for use in medical settings and clinical trials.
The Movano Evie is a smart ring designed for women, and Movano has always been clear about its ambition to have it classified as a medical device. The company’s roots are in the medical field, and it has previously stated its goal of securing FDA approval for all metrics on its smart ring.
The Movano Evie had a tough start with reliability and availability issues causing the ring to be relaunched in September 2024.
The EvieMED is separate from its consumer-grade smart ring and is specifically designed for medical and clinical use.
Movano is already collaborating with MIT on a large-scale study tracking the vitals of patients with Long COVID and Lyme disease.
The company is also finalizing a pilot program with a major health insurer, set to launch in early 2025 to manage health risks in high-risk populations.
We’ve spoken to Movano CEO John John Mastoratotoro at length about the company’s plans to bring medical-grade sensors to its products, and leverage the smart ring form factor to be used in medical settings:
“I always knew, having been in the medical device industry for my entire career, that it would be a huge opportunity, but it’s even bigger than I thought because I think healthcare is starting to transition more and more to the home and more and more virtually,” he told the PULSE podcast earlier this year.
The company is also looking at RF sensors for blood pressure and glucose tracking — so let’s hope this is just the start of FDA-approved metrics heading to its smart rings.
