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@faceheart.com.