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Movano on track for FDA approval of smart ring
- January 4, 2023
- Steve Rogerson
California-based Movano Health says it is on track to file its first FDA submission for its smart ring’s SpO2 and heart rate data following a successful trial.
The company also said it would be announcing this week at CES in Las Vegas a medical grade health wearable for women. Called Evie, it provides users with medical grade health data that are translated into personalised insights delivered through a mobile app, with no monthly subscription.
Preliminary results from the trial demonstrated high accuracy of SpO2 and heart rate data, bringing the company a step closer to developing a medical device.
The hypoxia trial was completed with the University of California in San Francisco (UCSF) to assess the accuracy of its smart ring’s blood oxygen saturation (SpO2) and heart rate data. In comparing the overall accuracy of the ring’s data with data from the study’s reference devices, Movano’s ring resulted in an approximate two per cent margin of error, well below the FDA consensus standard of four per cent for SpO2.
Additionally, the device measured heart rate that had root mean square error of approximately two BPM, which is also in line with the FDA’s requirements. Given these results, Movano Health expects to file for FDA clearance of these metrics in 2023.
Following a pilot study in July 2022, the latest study used the same protocol required by the FDA for the submission and involved eleven subjects of mixed genders and ethnicities. The participants, most of whom were between IV-VI, the darker skin tones on the Fitzpatrick scale, each wore a ring prototype, a Movano Health fingertip device and two reference devices. Within a controlled environment, each participant’s oxygen levels were driven down to as low as 70 per cent and then back up to 100 per cent to test the accuracy of the devices over the entire range of oxygen saturation including normal, mild, moderate and severe hypoxia.
The device data were compared and validated by arterial blood gas data.
“Our company is deeply committed to developing wearable devices that go beyond the status quo and give all consumers, regardless of gender and ethnicity, a higher level of confidence and trust in their health data,” said John Mastrototaro, CEO of Movano Health. “FDA approval remains one of the top priorities for our smart ring and the outstanding preliminary results we received from our pivotal study are extremely exciting. Clearance of a wearable device requires extensive investment in research and development, and it has been a central goal of ours since the beginning. Providing medical-grade heart rate and SpO2 data in the future will position us to help users better predict, prevent and understand health issues.”
Movano also plans to seek FDA clearance for Evie, which combines health and wellness metrics to give a full picture of one’s health: resting heart rate, heart rate variability, SpO2, respiration rate, skin temperature variability, period and ovulation tracking, menstrual symptom tracking, activity profile, including steps, active minutes and, calories burned, sleep stages and duration, and mood tracking.
These data are delivered through a mobile app that aims to simplify how data are presented, moving away from complex graphs and charts, and turning biometric data into actionable insights to help women make manageable lifestyle changes and take a more proactive approach to mitigating the risks of chronic disease.
“As a medical device, Evie will go beyond the status quo of other wearables on the market, and we believe it has the power to transform women’s lives and overall health,” said Mastrototaro. “We are bringing together medical grade biometric data and insights in a comfortable and contemporary wearable that allows women to take ownership of their unique health journey.”
Evie is being unveiled during CES alongside a demo showcasing its features and allowing consumers to gather live heart rate and SpO2 level readings within the app. It is made of polished aluminium and will come in three different finishes. The ring will be available in sizes 5 to 11, and its open design allows for a comfortable fit.
Founded in 2018, Movano is developing a suite of purpose-driven healthcare products to bring medical-grade, high-quality data to the forefront of consumer health devices. Featuring modern form factors, the devices capture a picture of a person’s vital health information and translate the data into personalised and intelligent insights that empower consumers to live healthier and more balanced lives. The aim is to help consumers, caretakers and healthcare professionals use daily medical-grade data as tools to monitor and manage their health proactively.