FaceHeart Vitals Software Development Kit (FH vitals SDK)

by FaceHeart  · Based in Taiwan → — AI-Based biosensing technologies & Contactless Vital Sign Measurement
Cardiology Internal Medicine Pulmonology

Regulatory Status Disclosed

Overview

FaceHeart Vitals Software Development Kit (FH Vitals SDK) is an AI-driven solution that transforms everyday devices with a camera into medical devices for contactless vital sign measurement. Leveraging remote photoplethysmography (rPPG) technology, the SDK analyzes subtle color changes in facial skin from a 50-60 second video recording to measure key physiological parameters. It has received FDA 510(k) clearance as a Class II Software as a Medical Device (SaMD) for heart rate (K223622) and respiratory rate (K243966) measurements. The SDK is designed for seamless integration into various platforms and operating systems, including smartphones (iOS/Android), tablets, computers (Windows), smart home devices, and embedded boards (Linux). FaceHeart Vitals SDK prioritizes data security and real-time processing through edge computing, eliminating the need for cloud-based analysis and ensuring robust protection of biometric and physiological data.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Contactless vital sign measurement via video
  • Measures Heart Rate (HR)
  • Measures Blood Pressure (BP)
  • Measures Oxygen Saturation (SpO2)
  • Measures Respiration Rate (RR)
  • Measures Heart Rate Variability (HRV)
  • Measures Stress Index
  • Detects Atrial Fibrillation (AFib) (additional parameter)
  • Edge computing for data privacy and real-time processing
  • Software-only SDK deployment, no specialized hardware required

Use Cases

  • Remote Patient Monitoring (RPM)
  • Telemedicine and Telehealth
  • Elderly care and Home-based care
  • Corporate wellness and insurance risk assessments
  • Pharmaceutical clinical trials
  • Maternal health monitoring

What Physicians Need to Know

Healthcare API Support (FHIR/HL7)
FaceHeart Vitals™ SDK supports FHIR-formatted data output for streamlined healthcare integration.
HIPAA-Compliant Infrastructure
FaceHeart Vitals™ SDK is designed with security in mind and supports enterprise compliance requirements, including alignment with HIPAA regulations through on-device processing and data minimization.
De-Identification Tools
FaceHeart Vitals™ supports privacy-focused deployment by enabling on-device processing, meaning FaceHeart does not store or access users' health data. Data ownership remains with the customer, and all data conversion and deletion are performed locally, with no facial recognition or identity matching conducted.
Sandbox/Testing Environment
A demo is available upon request to experience FaceHeart Vitals™ and understand its technology.
SDK Languages
The SDK is compatible with iOS, Android, web, and embedded platforms. While specific languages are not explicitly listed on the product page, a similar product's FDA filing mentions Python, Go, SQL, TypeScript, and Node.
Certification Program
FaceHeart Vitals™ (registered as FH Vitals SDK) is a Class II Software as a Medical Device (SaMD) and holds two FDA 510(k) clearances: Heart Rate (K223622) and Respiratory Rate (K243966). FaceHeart is actively working towards additional FDA clearances for blood pressure, oxygen saturation (SpO₂), and atrial fibrillation (AFib) detection.
Physician Tip

FaceHeart Vitals SDK offers a contactless and convenient way to obtain vital signs using standard smart devices, which can be particularly beneficial for telemedicine, remote patient monitoring, and chronic disease management. The FDA 510(k) clearances for heart rate and respiratory rate as a Class II SaMD provide a level of clinical credibility. The on-device processing minimizes data transmission and enhances patient privacy, aligning with HIPAA regulations. Physicians can leverage this technology to get objective vital sign data during virtual consultations and monitor physiological trends remotely, supporting early intervention and more informed clinical decisions. It's important to note that the product is currently validated for users aged 18 and above, with heart rate measurement for newborns in beta development.

FaceHeart Vitals™ SDK is designed for flexible and seamless integration into various platforms, including smartphones, tablets, computers, smart home devices, and embedded boards. It supports iOS, Android, web, and embedded platforms. The SDK's plug-and-play nature allows for easy integration into existing mHealth systems and applications, enabling scalable health solutions for telehealth, wellness, insurance, and corporate wellness.

Details

Category Developer Tools & APIs, Telehealth & Virtual Care, Wearables & Remote Monitoring (RPM)
Pricing Unknown
DeploymentSDK can be integrated into smartphones, tablets, computers, smart home devices, and embedded boards.
Mobile App1
API AvailableUnknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine, Pulmonology

What the Web Says

FaceHeart Vitals SDK is an AI-powered software development kit that enables contactless measurement of vital signs like heart rate, respiratory rate, blood pressure, oxygen saturation, and heart rate variability using a standard camera on smartphones, tablets, laptops, or desktops. It has received FDA 510(k) clearance as a Class II Software as a Medical Device (SaMD) for heart rate and respiratory rate measurements, with ongoing efforts for other vital signs. The technology utilizes remote photoplethysmography (rPPG) to detect subtle facial color changes and has undergone extensive clinical trials.

Overall: Positive

Strengths

  • Contactless vital sign measurement using standard cameras.
  • FDA 510(k) clearance for heart rate and respiratory rate as a Class II SaMD.
  • Measures multiple vital signs including heart rate, respiratory rate, blood pressure, oxygen saturation, and heart rate variability.
  • High accuracy demonstrated in clinical trials (e.g., respiratory rate within ±2 bpm).
  • Supports edge computing for data security and real-time processing, reducing latency and security concerns.
  • Flexible integration into various devices and platforms (iOS, Android, web, embedded systems).

Limitations

  • No specific cons were found in the provided search results.
  • Limited public reviews from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra were found.
  • The FDA clearance for blood pressure and oxygen saturation is still in progress.

Based on reviews from: FaceHeart Official Website, PR Newswire, RadAISlice, Institute for Biotechnology and Medicine Industry (IBMI), FDA 510(k) Premarket Notification, G2 (no specific reviews for FaceHeart Vitals SDK found, only general healthcare analytics)

Last updated: 2026-10-26

Ratings & Reviews

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Press & Coverage

FaceHeart
FaceHeart has Obtained FDA 510(k) Clearance for its Video-Based Contactless Vital Sign Measurement
FaceHeart announced it received FDA 510(k) clearance for FaceHeart Vitalsu2122 (registered as FH Vitals SDK), making it the first FDA-Cleared Class II SaMD for heart rate measurement that transforms everyday devices with a camera into medical devices.
2023-10
FaceHeart
FaceHeart Received Another FDA Clearance for its Contactless Video-Based Vital Sign Measurement of Respiratory Rate
FaceHeart Corporation received another FDA 510(k) clearance for FaceHeart Vitalsu2122 (registered as FH Vitals SDK-RR) as a Class II SaMD for respiratory rate measurement.
2025-04
FDA
510(k) Premarket Notification - FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
This FDA document details the 510(k) premarket notification for FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) for respiratory rate measurement, granted on April 9, 2025.
2025-04
PRNewswire
CES 2022: FaceHeart Corp. Launches Visual Recognition AI Tech to Measure Vital Signs
FaceHeart Corporation launched its AI technology, FaceHeart Vitalsu2122 SDK, at CES 2022, enabling seamless vital sign measurement using existing consumer devices like smartphones and tablets.
2022-01
FaceHeart
FaceHeart has been selected for inclusion on the Forbes Asia 100 to Watch 2025 list
FaceHeart was selected for the Forbes Asia 100 to Watch 2025 list, recognizing its AI-powered contactless vital sign measurement solution, FaceHeart Vitalsu2122.
2026-04
FaceHeart
News - FaceHeart
This news section from FaceHeart's website lists various achievements, including FDA clearances for FH Vitals SDK and awards.
unknown
FDA
K223622 - 510(k) Premarket Notification - FaceHeart Vitals Software Development Kit (FH vitals SDK)
This FDA document details the 510(k) premarket notification for FaceHeart Vitals Software Development Kit (FH vitals SDK) for pulse rate measurement, cleared on September 1, 2023.
2023-09
HaRi
FaceHeart Vitals Software Development Kit (FH vitals SDK) - HaRi
HaRi provides an overview of the FaceHeart Vitals Software Development Kit (FH vitals SDK), highlighting its regulatory registrations, clearances, and safety data across various health authorities.
2023-09

Videos

Product demos, reviews, and walkthroughs for FaceHeart Vitals Software Development Kit (FH vitals SDK).

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-21 | First Added: 2026-04-21
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