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MagyarCES 2024 | FaceHeart granted FDA clearance for Vitals AI software that measures vital signs by examining remote patient videos
The US FDA has granted 510(k) clearance to FaceHeart Vitals AI software. This innovative software examines minute-long videos of patients recorded remotely to measure their heart rate, heart rate variability, blood pressure, oxygen saturation, and respiration rate. Atrial fibrillation can also be detected by the AI.
During the worldwide COVID-19 pandemic, many businesses shifted to remote services and work. However, medical providers had to measure patient vital signs in person, so this exposed many nurses and health care providers to needless infections of minor diseases. One of the missing components of telehealth is the measurement of vital signs, making the diagnosis of developing, critical health problems more difficult for doctors.
The FaceHeart Vitals is the first software as a medical device (SaMD) for heart rate measurement and a CES 2024 Innovation Award Honoree. Vitals utilizes remote photoplethysmography (rPPG), careful measurements in the minute color changes that occur with each heart beat in lit skin, along with other AI processing to extract vitals from the video images. The software can use cameras in common Samsung and Apple smartphones as well as laptop webcams for this.
The AI algorithm has been trained on data from thousands of people and tested on over 500 study participants for the FDA application. The ability of the SaMD to measure heart rate within 3 beats per minute versus a clinical monitor occurred in 93.8% of study participant measurements on average.
Naturally, the field of SaMD AI is evolving, so accuracy will improve with further development. In the meantime, if you are worried about developing heart disease or already suffer from such, why not use a validated blood pressure device at home (like this at Amazon) to help monitor your health.
FaceHeart has Obtained FDA 510(k) Clearance for its Video-Based Contactless Vital Sign Measurement
October 30, 2023
FaceHeart, an AI-based provider of healthcare solutions, announced that it officially received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its video-based contactless vital sign solution, FaceHeart Vitals™.
FaceHeart Vitals™ (registered as FH Vitals SDK) is the first FDA-Cleared Class II SaMD (software as a medical device) for heart rate measurement (K223622) in the market, that transforms everyday devices with a camera into medical devices.
“As we shift towards digitalization and integration paradigms, FaceHeart plans to streamline accessibility, enhance healthy outcomes, and transform the ways we can approach healthcare,” said Prof. Bing-Fei Wu, Founder & CEO of FaceHeart.
By analyzing the RGB signals from a 60s video recording, FaceHeart Vitals™ allows anyone to measure their vital signs, including heart rate (HR), blood pressure (BP), oxygen saturation (SpO2), and respiration rate (RR) anywhere, enabling high-quality healthcare accessible in a variety of home and work spaces.
To verify its measuring accuracy and optimize the underlying AI algorithms, FaceHeart has conducted numerous clinical trials with hospitals and research facilities in Taiwan and the US, collecting more than 150 million datasets from 4,000+ testers.
FaceHeart Vitals™ provides comprehensive support for a wide range of edge devices and online services. In addition to transferable data formats, the software development kit (SDK) can be integrated with various platforms and operating systems, such as smartphones (iOS/Android), tablets, computers (Windows), smart home devices, and embedded boards (Linux).
Moving forward, FaceHeart will continue to invest in clinical trials to improve medical accuracy and progress through its global medical clearance roadmap, accelerating digital health solutions such as remote patient monitoring, telemedicine, pharmaceutical clinical trials, corporate wellness, and insurance worldwide.
About FaceHeart
FaceHeart Corporation improves human health through its expertise in artificial intelligence, computer vision, and deep learning. Through FaceHeart's technology, individuals can access high-quality health services with minimal accommodations.
For further information, please contact us at marketing(at)faceheart.com.
