- Developed by FaceHeart, FH Vitals SDK-RR has obtained FDA Clearance. This is the second 510(k) class II SaMD (Software as a Medical Device) FaceHeart received from the FDA.
- FaceHeart Vitals™ is a video-based, contactless vital sign measurement SDK that can be integrated into devices such as smartphones seamlessly, providing heart rate, respiration rate, blood pressure and other vital sign readings in 50 seconds.
TAIPEI, May 1, 2025 /PRNewswire/ — FaceHeart Corporation (FaceHeart), an AI health tech company, has received another FDA 510(k) clearance for FaceHeart Vitals™, its contactless video-based vital sign solution.
FaceHeart Vitals obtains Second FDA 510k Clearance under class II SaMD (Software as a Medical Device)
On top of heart rate measurement, FDA granted 510(k) clearance (k243966) to FaceHeart Vitals™ (registered as FH Vitals SDK-RR) as a Class II SaMD (Software as a Medical Device) for respiratory rate measurement on April 9th, 2025. The respiratory rate measurements derived from the FH Vitals SDK-RR demonstrated deviations consistently within ±2 breaths per minute (bpm) across all devices.
FaceHeart Vitals™ is the first FDA-cleared software development kit (SDK) solution that enables contactless video-based vital sign measurement—including heart rate (HR), respiratory rate (RR), blood pressure (BP), oxygen saturation (SpO2), and heart rate variability (HRV)—via a facial scan on built-in camera of smartphones within 50 seconds. It leverages the remote photoplethysmography (rPPG) technology that extracts subtle color changes of the facial skin. In addition, by conducting the analysis via edge computing without cloud service eliminates network latency and addresses security concerns at the same time.
Receiving FDA clearance not only represents the recognition of FaceHeart’s undivided attention to clinical trials, but also reinforces its commitment to deliver accessible and reliable contactless vital sign measurement to the general public. Designed with the capability to be seamlessly integrated into common edge devices such as smartphones (iOS/Android), tablets, laptops/desktops (Windows) etc., FaceHeart Vitals™ empowers preventive health, telemedicine, elderly care, and chronic disease management with real-time, user-friendly and accurate contactless vital sign measurement, transforming readily available devices into medical-grade solutions instantly.
“Following the first FDA Clearance on heart rate in 2023, this FDA clearance on respiratory rate marks a milestone and commitment of FaceHeart in providing the healthcare industry with the most reliable contactless vital sign measurement solution,” said Dr. Meng Liang Chung, Co-founder and Vice President of FaceHeart Corporation. “As demands for more personalized and effective healthcare solutions arise globally, FaceHeart’s contactless vital sign measurement solution undoubtedly plays a pivotal role in proactive and preventive healthcare-related services—helping people live not just longer, but healthier lives within reach.”
About FaceHeart
FaceHeart Corporation (https://faceheart.com/) is a leading health technology company that improves human health with its expertise in artificial intelligence, computer vision, and deep learning. Through FaceHeart’s technology, individuals can access high-quality health measurements with a simple 50-second facial scan.
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