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.