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Movano announces Evie Ring FDA submission and launch date delay

A 501(k) for the Movano Evie Ring has been submitted to the FDA. (Image source: Movano)
A 501(k) for the Movano Evie Ring has been submitted to the FDA. (Image source: Movano)
Movano has submitted a 510(k) to the FDA for its Evie Ring, a first for the brand. The filing includes data demonstrating the accuracy of the wearable’s heart rate and SpO2 sensors. However, a later-than-expected submission date has led to the announcement of a delay in the product’s launch.
Biotech Wearable

Movano has announced its first FDA filing for the upcoming Evie Ring. The company recently submitted a 510(k) premarket notification, which is currently under review by the agency. The filing includes data surrounding the wearable’s performance from Movano’s recent experiments. 

For example, a study with the University of California, San Francisco (UCSF) showed that the SpO2 monitor has a 2% margin of error, and a separate trial demonstrated that the heart rate monitor was accurate to within 1 BPM; both results improved upon the minimum requirements of the FDA. As well as measuring SpO2, resting heart rate and heart rate variability, the gadget will allow you to track your respiration rate, skin temperature variability, activity, sleep and mood. The data collected by the wearable will be viewable in an accompanying app, with the company aiming to provide easily understandable insights.

Movano announced a September launch date for its Evie Ring in the US earlier this year. However, given the later-than-planned submission to the FDA, the company now aims to release the device in November, sometime before Black Friday. While the exact launch date of the health-tracking wearable remains to be seen, the brand has confirmed that it will retail for US$269, with no monthly subscription.

The Movano Evie Ring. (Image source: Movano)
The Movano Evie Ring. (Image source: Movano)

Source(s)

Movano, PR Newswire (1 and 2), Wareable

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> Expert Reviews and News on Laptops, Smartphones and Tech Innovations > News > News Archive > Newsarchive 2023 08 > Movano announces Evie Ring FDA submission and launch date delay
Polly Allcock, 2023-08-15 (Update: 2023-08-15)