FaceHeart Vitals™: Revolutionizing Contactless Vital Sign Measurement

Published Date: May 1, 2025

By News Release

FaceHeart Corporation, an AI-driven health tech company, has achieved another significant milestone by obtaining FDA 510(k) clearance for its innovative contactless vital sign solution, FaceHeart Vitals™. The clearance, issued on April 9th, 2025, specifically approves the system's ability to measure respiratory rate (registered as FH Vitals SDK-RR) as a Class II Software as a Medical Device (SaMD). This approval comes on the heels of FaceHeart's earlier clearance for heart rate measurement in 2023, marking a continued advancement in the company's commitment to enhancing healthcare accessibility.

FaceHeart Vitals™ demonstrated exceptional accuracy during clinical trials, with respiratory rate measurementsconsistently showing deviations within ±2 breaths per minute (bpm) across all tested devices. This consistent precision, combined with the previous clearance for heart rate (HR) measurement, strengthens the solution's credibility and applicability in real-world healthcare scenarios.

FaceHeart Vitals™ represents a breakthrough in contactless vital sign measurement technology. It is the first FDA-cleared SDK that enables the measurement of heart rate, respiratory rate, blood pressure, oxygen saturation (SpO2), and heart rate variability (HRV) through a simple facial scan using a smartphone's built-in camera. The entire process takes just 50 seconds, leveraging remote photoplethysmography (rPPG) technology to detect subtle color changes in the facial skin.

The technology also prioritizes data security and real-time processing through edge computing, eliminating the need for cloud-based analysis. This approach significantly reduces network latency and mitigates potential security concerns, making it highly suitable for telemedicine, preventive health, elderly care, and chronic disease management.

FaceHeart Vitals™ is designed to be seamlessly integrated into a wide range of common edge devices, including:

Smartphones (iOS/Android)
Tablets
Laptops and desktops (Windows)

This compatibility ensures that the solution can be widely adopted, transforming readily available personal devices into medical-grade tools. The technology empowers healthcare providers and patients alike with real-time, user-friendly, and accurate contactless vital sign measurement, enabling proactive healthcare management.

The FDA's recognition of FaceHeart Vitals™ as a reliable medical device underlines the company’s dedication to clinical validation and healthcare innovation. By making vital sign monitoring more accessible, FaceHeart is addressing the growing global demand for personalized and efficient healthcare solutions.

In a statement, Dr. Meng Liang Chung, Co-founder and Vice President of FaceHeart Corporation, emphasized the importance of this achievement:

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. 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.

The recent FDA clearance not only acknowledges the reliability and accuracy of FaceHeart Vitals™ but also solidifies its role in the evolving healthcare landscape. As more healthcare providers and patients embrace contactless monitoring, the use of AI-driven technologies like FaceHeart Vitals™ will likely become a cornerstone of modern telehealth and preventive care strategies.

By integrating this advanced solution into everyday devices, FaceHeart is transforming routine health checks, making medical-grade vital sign measurements more accessible and convenient than ever before.