20+ Clinical Trials
20+
Conducted in collaboration with leading hospitals and research institutions, validating performance against medical-grade reference standards.
Clinically Validated.
Built for Trust.
Developed through rigorous clinical research and validated against medical reference standards. With US FDA clearances and continuous real-world evaluation, our technology is designed to deliver reliable and scalable health insights.
FDA-Cleared Credibility
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.
Heart Rate (HR)
- U.S. FDA 510(k) Clearance (Class II SaMD)
- 510(k) Number: K223622
Respiratory Rate (RR)
- U.S. FDA 510(k) Clearance (Class II SaMD)
- 510(k) Number: K243966
300M+ Data Points
300M+
Powering AI-driven algorithms and continuous model refinement for robust and reliable physiological signal analysis.
36,000+ Subjects
36,000+
Representing diverse populations, supporting inclusive performance across age groups, skin tones, and real-world conditions.
2 US FDA Clearances
2
For HR and RR measurement as Class II Software as a Medical Device (SaMD), meeting established standards for safety and performance.
20+ Clinical Trials
20+
Conducted in collaboration with leading hospitals and research institutions, validating performance against medical-grade reference standards.
300M+ Data Points
300M+
Powering AI-driven algorithms and continuous model refinement for robust and reliable physiological signal analysis.
36,000+ Subjects
36,000+
Representing diverse populations, supporting inclusive performance across age groups, skin tones, and real-world conditions.
2 US FDA Clearances
2
For HR and RR measurement as Class II Software as a Medical Device (SaMD), meeting established standards for safety and performance.
Medical Grade Accuracy
Heart Rate
- ±3 beats per minute (bpm)
Respiratory Rate
- ±2 breaths per minute (bpm)
Blood Pressure
- ≤10 mmHg
Atrial Fibrillation
- 90% Accuracy
Oxygen Saturation
- ≤3.5%
Clinically Validated Technology
At FaceHeart, research and innovation are at the core of our development. Our rPPG-based technology is continuously refined and validated through clinical studies and scientific publications to ensure accuracy and reliability in every measurement.
- Clinical Validation
- Trusted Accuracy
- Medical Grade
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