FDA Clearance

The First FDA-Cleared Contactless Video-Based Vital Sign Solution

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

FaceHeart currently holds two FDA 510(k) clearances:

  • Heart Rate (K223622)
  • Respiratory Rate (K243966)

We believe contactless vital sign measurement should bring both comfort and peace of mind at ease, with the accuracy cleared by one of the strictest regulations.

FDA 510(k) clearance for RR
How it works

3 Steps to Your Health Check

Enter Basic Information

Provide a few basic details to personalize your measurement:
1. Gender
2. Birth year
3. Height / Weight
4. Usual blood pressure range

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Complete a Facial Scan

Using a standard camera on your mobile devices, FaceHeart Vitals™ performs a 50-second facial scan to capture physiological signals.

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Receive Your Health Report

View your vital signs and health insights instantly, including key physiological data and wellness indicators.


Health

Health Metrics We Measure

With rPPG technology, FaceHeart Vitals™ analyses the subtle color change reflected on a face's blood vessels to measure key health indicators in just 50 seconds - without any contact.

View All Metrics
Heart Rate

Heart Rate

Number of heart beats per minute (bpm)

Respiratory Rate

Respiratory Rate

Number of breaths per minute (bpm)

Blood Pressure

Blood Pressure

The force of blood pushing against the artery walls (mmHg)

Oxygen Saturation

Oxygen Saturation

Percentage of oxygenated hemoglobin in bloodstream

Atrial Fibrillation

Atrial Fibrillation

A type of arrhythmia that increases risk of stroke & other heart-related conditions

Heart Rate Variability

Heart Rate Variability

The variations in the time interval between heartbeats

Stress Index

Stress Index

Relative stress levels based on measured HRV

Cardio Age

Cardio Age

Whether your heart is performing younger or older than your chronological age

Cardio BMI

Cardio BMI

How your heart function aligns with typical patterns across different BMI ranges

10-Y Cardiovascular Risk

10-Y Cardiovascular Risk

The likelihood of having a stroke or heart attack in 10 years

PRQ Index

PRQ Index

The ratio of heart rate (HR) to respiration rate (RR). Represent a specific aspect of cardiorespiratory interaction

Six Wellness Indicators

Six Wellness Indicators

Including Sleep, Activity, Equilibrium, Metabolism, Relaxation, and Health


Benefits

Why FaceHeart

Contactless solution, seamless integration, and medical-grade accuracy

FDA 510(k)-Cleared Accuracy

FDA 510(k)-Cleared Accuracy

FaceHeart has obtained two FDA 510(k) clearances for heart rate (K223622) and respiratory rate (K243966).

Fully Contactless

Fully Contactless

No need for wearables or additional devices. Measurements are conducted completely contactlessly on any smart device with a camera.

Edge Computing Capability

Edge Computing Capability

FaceHeart enables its AI-driven software to be deployed on small devices, reducing latency and eliminating security issues.

User Friendly Procedure

User Friendly Procedure

Users are allowed to keep 30-150 cm (1-5 ft) away from the camera, without the need to remove makeup and glasses.

Seamless, Flexible Embedding

Seamless, Flexible Embedding

FaceHeart Vitals™ SDK can be integrated into smartphones, tablets, computers, smart home devices, and embedded boards.

Enhance Health Access

Enhance Health Access

Enable anyone, anywhere to access vital health insights through a simple, camera-based measurement by everyday devices.

Market Recognized Technology

Internationally Recognized 10+ Awards

2025 CES Innovation Award Honoree

2025 CES Innovation Award Honoree

2024 CES Innovation Award Honoree

2024 CES Innovation Award Honoree

Best Biometric Sensor Solution” in MedTech Breakthrough Program

Best Biometric Sensor Solution” in MedTech Breakthrough Program

2025 Symbol of National Quality

2025 Symbol of National Quality

2025 CES Innovation Award Honoree

2025 CES Innovation Award Honoree

2024 CES Innovation Award Honoree

2024 CES Innovation Award Honoree

Best Biometric Sensor Solution” in MedTech Breakthrough Program

Best Biometric Sensor Solution” in MedTech Breakthrough Program

2025 Symbol of National Quality

2025 Symbol of National Quality

2025 MEDICA Top 12 Health Techpreneur

2025 MEDICA Top 12 Health Techpreneur

2023 12th MEDICA Start-up Competiton Finalist

2023 12th MEDICA Start-up Competiton Finalist

2025 National Healthcare Quality Award

2025 National Healthcare Quality Award

2026 Hong Kong Medtech Innovation World Cup Finalist

2026 Hong Kong Medtech Innovation World Cup Finalist

2025 MEDICA Top 12 Health Techpreneur

2025 MEDICA Top 12 Health Techpreneur

2023 12th MEDICA Start-up Competiton Finalist

2023 12th MEDICA Start-up Competiton Finalist

2025 National Healthcare Quality Award

2025 National Healthcare Quality Award

2026 Hong Kong Medtech Innovation World Cup Finalist

2026 Hong Kong Medtech Innovation World Cup Finalist

Solutions

Applications & Use Cases

Turn everyday moments into continuous health insights

Empower users to measure vital signs anytime using just their smartphone. Enable comfortable, frequent monitoring without wearables, helping individuals build awareness, track trends over time, and make more informed lifestyle decisions—all within a seamless mobile experience.

Our partners

Trusted by Industry Leaders

FAQs

Frequently Asked Questions

With only a single RGB camera, FaceHeart Vitals™ measures the following health parameters:

  • Heart Rate (HR, FDA-cleared)
  • Blood Pressure (BP)
  • Respiratory Rate (RR, FDA-cleared)
  • Oxygen Saturation (SpO2)
  • Heart Rate Variability (HRV)
  • Stress Index
  • Cardiovascular BMI
  • Cardiovascular Age
  • Atrial Fibrillation (AFib)

There are also other key biomarkers in the beta version: HbA1c, Hemoglobin, and Cholesterol.

FaceHeart Vitals™ uses remote photoplethysmography (rPPG) technology to measure vital signs through a standard camera.

By analyzing subtle changes in facial skin color caused by blood circulation, our AI-powered algorithms can estimate key health metrics in real time—without physical contact, wearables, or specialized hardware.

To learn more about the science and technology behind FaceHeart Vitals™, visit Technology page.

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).

Until 2026, FaceHeart Vitals™ has received two FDA clearances:

  1. Pulse Rate Measurement (k223622)
  2. Respiratory Rate Measurement (k243966)
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