Award-Winning Technology

FaceHeart’s AI-powered vital-sign measurement technology has received international recognition for its innovation and clinical rigor. By enabling contactless monitoring through standard cameras, our solutions are redefining accessible health measurement.

Leading with Dual FDA-Cleared Technology

FaceHeart Vitals™ (registered as FH Vitals SDK) is the first video-based vital sign solution to receive FDA 510(k) clearance as a Class II Software as Medical Device(SaMD).

Now, FaceHeart owns two FDA 510(k) clearances, establishing themselves as the most reliable contactless vital sign solution in the market.

Class II SaMD

Heart Rate (HR)

U.S. FDA 510(k) Clearance (Class II SaMD)
510(k) Number: K223622

510(k) Summary Report (HR)

Class II SaMD

Respiratory Rate (RR)

U.S. FDA 510(k) Clearance (Class II SaMD)
510(k) Number: K243966

510(k) Summary Report (RR)

Recognized by Global Innovation Leaders

FaceHeart is recognized by leading global platforms for innovation in health technology, reflecting our commitment to advancing contactless health monitoring through AI, clinical validation, and real-world impact.

Hong Kong MedTech Innovation World Cup® 2026 Top 11
CES 2025 Innovation Awards Honoree
CES 2024 Innovation Awards Honoree
MEDICA 2025 Top 12 Health Techpreneur

10+ awards

Award-Winning Technology

With FaceHeart's state-of-the-art solution, we have enlightened the digital health worldwide with FDA-cleared contactless vital sign measurement, anytime, anywhere.