Movano has started blood pressure and glucose trials using its radio frequency (RF) sensor, as it looks to bring medical-grade metrics to consumer wearables.
A huge theme of our recent 2023-24 predictions round-up was wearables evolving into medical devices in their own right, and beyond the wellness ones we have today.
Movano's strategy epitomizes this vision, and the company is seeking to get FDA clearance for multiple elements of its Movano Evie ring in order to make it a certified medical device (more on that shortly).
Movano has also started internal trials of its experimental RF sensor, which we reported on last year. Movano’s chip uses radio frequency technology to look under the skin, rather than the optical sensor.
In an interview with Wareable, Movano CEO John Mastrototaro revealed that the company had now miniaturized the chip and that it was starting trials focusing on blood pressure and glucose measurement.
Blood pressure and glucose trials
"We’ve developed this chip for the measure of blood pressure, and then glucose, so we're really excited about initiating the trials. We will start the blood pressure next week, and then we'll start the glucose stuff thereafter. So, over the course of the next couple of months, we'll have conducted a lot of testing," he said.
Mastrototaro confirmed that these were internal trials, and for clearance by the FDA.
"We'll call them algorithm development trials, where we look to develop models from the data we collect that can translate the signals we measure into blood pressure," he said.
"In the prior studies, we were not accurate enough for saying FDA clearance for blood pressure, for example. Not quite there yet," Mastrototaro continued.
“Every time we've scaled down the technology more and more, we seem to get better, more accurate data. We're cautiously optimistic that we'll start to get some nice clean signals and continue to have improved accuracy.”
While the idea of an RF sensor that tracks blood pressure without cuff validation is nowhere near commercially ready, the company’s Evie smart ring is due in the first half of 2023.
And Movano aims to have multiple features cleared by the FDA for launch so that the Evie can be sold as a medical device.
Making a medical-grade smart ring
"One of the things that are important to us is becoming a medical device, and being really the only medical device company that has a wearable," Mastrototaro continued.
Movano is looking to clear a wide range of metrics, from heart rate to SpO2 and even sleep analysis, including sleep apnea detection with the FDA. And while Mastrototaro claims that many rivals have cleared the algorithms used to analyze data from sensors, Movano will seek to validate both the hardware and software.
"We've completed the pivotal hypoxia, heart rate study, and got phenomenal results," he revealed.
But Mastrototaro revealed that the company was confident in its data – it was just a case of presenting that to the FDA:
"We certainly have the data commensurate with an FDA clearance right now. What we need to do, though, and what we're working on, is putting together all the rest of the FDA package."
The idea that Evie could offer medical grade analysis has got healthcare companies interested, according to Mastrototaro. And he believes that this could lead to Evie being used to monitor patients at home, outside of healthcare settings.
And the belief that Evie could appeal to medical providers has given Movano confidence in its potential for B2B sales - so much so that the company doesn’t plan to offer a subscription to its consumer users. That means it should drastically undercut Oura in terms of cost.
"Maybe we will do a subscription model for the B2B front, as it relates to what we do in the healthcare space. That's one of the real advantages we have as a medical device company," Mastrototaro said.
"Women told us they don't want any more subscriptions. So we have made a decision based upon listening to them that we will sell the first product for under $300."
The key to all of this will be swiftly getting FDA clearance for this wide range of metrics, and avoiding the pitfalls of Withings, which spent years in regulatory stasis with its ScanWatch.
But it’s clear that the idea of medical-grade consumer wearables is coming – and Movano could deliver it faster than most people predicted.
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