Image source: Movano Health

Beyond fitness tracking: Evie Ring’s journey towards FDA clearance

Movano’s Evie Ring is on the cusp of becoming one of the first consumer wearables to receive FDA clearance. Movano Health has announced that the device will hit the market in September with a price tag of $269. By eliminating a monthly subscription, Evie Ring will be a more affordable alternative to Oura ring, while monitoring much the same metrics.

A number of other companies are working on their own smart ring solutions. And it’s not just lesser known names. Apple is a company that has figured in this conversation for years now, but with little to show. Other brands have started to register smart ring patents, too.

One of these is Fitbit. With Google’s money behind it, perhaps we might finally see a smart ring from the San Francisco wearables pioneer. Another is Oppo. The company has registered a smart ring patent with the Chinese authorities last year. Samsung is amongst these, as well.

Essential readingBest fitness trackers and health gadgets

We are not sure when and if we will see smart rings from these companies. Just because they have filed patents does not mean they will produce working devices. If nothing else, it does show is that they are thinking of exploring the smart ring space. But there are already a few quite good options out there such as RingConn and Ultrahuman.

Movano’s smart ring will be called Evie

The Movano ring is something that is currently under development. The device was originally demoed at CES 2022 in Las Vegas. Another demo followed at CES 2023 earlier this year.

This will be the first such product from health tech company Movano. The ring will be called Evie. As its name implies, this is a device designed primarily for women.

Evie is actually a play on the word “evidence”. Meaning, the ring will deliver trusted evidence. To this end the company is in the process of gaining approval from the US Food and Drug Administration (FDA). The goal is to ultimately for Evie ring to have Class II designation as a medical device.

Movano Ring
Image source: Movano

As far as what type of evidence, Evie will be able to monitor a slew of health metrics. This includes activity, sleep, heart rate, heart rate variability (HRV), sleep, restoration, temperature, blood oxygen, steps, calories, menstrual cycle, ovulation and mood. That’s a very similar list that the $300 Oura Ring currently monitors.

The accompanying smartphone app will spit out easy to understand actionable insights on the data the ring collects. The idea is to link the cause and effect of individual metrics. For example, you’ll be able to know how your exercise habits impact your sleep patterns, HRV and more. That way you’ll be able to take “a more proactive approach to mitigating the risks of chronic disease.”

Movano Evie

The ring itself is circular, but it is not a solid circle. There’s a small gap. This appears to be more a design characteristic that allows the ring to expand a little bit over the knuckle. It should also help if your finger swells. As far as build, Evie is made of metal with a resin inner section.

Users will be able to choose between silver, gold and rose gold finishes. All of these will come in sizes between 5 and 11.

Movano Ring
Image source: Movano

However, the company’s ambitions do not end there. In an interview a few months ago, it was revealed that the ring might eventually be able to monitor glucose non-invasively and provide cuff-less blood pressure information. The proprietary radio frequency technology that is used to obtain this type of data is undergoing clinical trials. If this is proven successful, it will be a game-changer.

FDA approval

In a significant development, Movano’s Evie Ring has recently taken a major step towards becoming one of the first consumer wearable devices to be cleared for clinical use. In the past few days, the Evie team has submitted their first 510(k) application to the U.S. Food and Drug Administration (FDA) for medical device clearance. This application pertains to Evie’s pulse oximeter, which includes heart rate and blood oxygen saturation (SpO2) data. The submission has successfully passed the initial review for completeness and is now under full review by the FDA.

The Evie Ring has shown promising results in clinical trials, exceeding FDA standards. When compared with arterial blood gas data, the ring’s data accuracy resulted in an approximate 2% margin of error, well below the FDA guidance of 3.5% for SpO2. In terms of pulse rate accuracy, the Evie Ring demonstrated a margin of error of just 1 beat per minute (BPM), surpassing the FDA’s requirements.

The Evie team expects to receive a decision from the FDA on their pulse oximeter submission within six months from their submission date. If the Evie Ring receives FDA clearance as a medical device, it would be one of the first consumer wearables to achieve this status. This would not only validate the ring’s accuracy standards but also position Evie as a trusted device for both users and healthcare professionals.

However, it’s important to note that FDA clearance does not guarantee insurance coverage for the device initially. The Evie team is actively working towards making insurance coverage a possibility in the future.

Movano Evie smart ring: Price and release date

Now we get to the cost. The good news is that there is no subscription. Evie’s main competitor Oura Ring will set you back around $300. But on top of this you need to fork out for a $6 monthly subscription (after the initial six months). Regardless of the FDA’s decision, there will just be the upfront cost of Evie which will be $269.

As far as a launch date, Movano has just announced that ring availability will begin in September in the US. Europe and Australia should follow soon after.

So a few things to look forward to here. A smart ring without a subscription, something that will eventually have FDA approval, and women specific features. Only time will tell if Movano’s product proves to be a success.

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Marko Maslakovic

Marko founded Gadgets & Wearables in 2014, having worked for more than 15 years in the City of London’s financial district. Since then, he has led the company’s charge to become a leading information source on health and fitness gadgets and wearables.

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