FaceHeart Vitals Software Development Kit (FH vitals SDK)

by FaceHeart  · Based in Taiwan →Contactless Vital Sign Measurement Powered by AI Biosensing
Cardiology Internal Medicine Pulmonology

Contact for pricing
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

HIPAA-Compliant Infrastructure
FaceHeart Vitals SDK is designed with HIPAA compliance in mind, ensuring data encryption and secure transmission. It prioritizes data security through edge computing, processing AI-driven algorithms directly on devices, which eliminates the need for cloud-based analysis of raw image data and significantly mitigates security concerns. All image data are discarded upon completion, and FaceHeart does not store any user data, including images or basic health information.
De-Identification Tools
While explicit de-identification tools are not mentioned, the architecture of the FH Vitals SDK inherently addresses de-identification by processing data via edge computing and not storing any user image data. This approach minimizes the handling of identifiable raw data.
Medical Terminology Support
The SDK measures standard vital signs including Heart Rate (HR), Blood Pressure (BP), Respiration Rate (RR), Oxygen Saturation (SpO2), Heart Rate Variability (HRV), Stress Index, and Atrial Fibrillation (AFib). Beta biomarkers such as HbA1c, Hemoglobin, and Cholesterol are also being developed. The output parameters are in commonly understood medical terms.
Sandbox/Testing Environment
FaceHeart offers a web-based demo and a 'WALK-THROUGH' to experience the FH Vitals SDK, allowing developers and potential users to test and understand its capabilities.
SDK Languages
The FH Vitals SDK supports multiple operating systems including iOS (12 and above), Android (8.1 and above), Windows (10 and above), and Linux. It also provides a Web Integration Tool (JavaScripts) and supports web-based (HTML-5) pages for cloud computing integrations.
Rate Limits & Pricing
Specific details on rate limits and pricing are not publicly available. FaceHeart encourages contacting their team for customized demonstrations and likely provides pricing upon inquiry.
Certification Program
FaceHeart Vitals SDK has received multiple FDA 510(k) clearances as a Class II Software as a Medical Device (SaMD). This includes clearance for Heart Rate measurement (K223622) in September 2023 and Respiratory Rate measurement (K243966) in April 2025. The company is actively pursuing additional medical certifications across various regions and for other vital signs. Other product certifications include Australia RCM, Canada ICES-003 / IC, China CCC / SRRC, Chile SUBTEL, Japan VCCI / MIC, Taiwan BSMI /NCC, USA FCC, UK UKCA, and EN60601-1-2.
Physician Tip

FaceHeart Vitals SDK offers a non-invasive, contactless method for measuring vital signs (HR, RR, BP, SpO2, HRV, Stress Index, AFib) using standard cameras, making it highly accessible for remote patient monitoring, telemedicine, elderly care, and chronic disease management. The SDK has received FDA 510(k) clearance for Heart Rate and Respiratory Rate as a Class II SaMD, indicating medical-grade accuracy. It's crucial to remember that the results are intended to complement, not replace, professional medical care, and the SDK is indicated for adults 18 years or older who do not require critical care or continuous monitoring, and not for patients with known or suspected heart arrhythmias. The emphasis on edge computing and non-storage of image data ensures strong patient data privacy and HIPAA compliance.

The FH Vitals SDK is designed for flexible and seamless integration into a wide range of applications and devices. It supports various operating systems including iOS, Android, Windows, and Linux, and offers web integration tools (JavaScripts, HTML-5). The SDK can be integrated into existing platforms, apps, or web pages, leveraging existing device cameras without requiring specialized hardware. It also supports EMR connectivity, with a noted integration with the EPIC Electronic Health Records system, facilitating data flow into healthcare workflows.

Details

Category Developer Tools & APIs, Telehealth & Virtual Care, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing Custom pricing based on integration needs; not publicly disclosed.
DeploymentSDK for integration into various devices; on-device processing (edge computing).
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

FaceHeart Vitals SDK received FDA 510(k) clearance as a Class II SaMD for heart rate measurement (K223622) in September 2023 and for respiratory rate measurement (K243966) in April 2025.

Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine, Pulmonology

What the Web Says

FaceHeart Vitals SDK (FH Vitals SDK) is generally perceived as an innovative solution for remote health monitoring, leveraging AI and computer vision to measure vital signs from video feeds. Reviewers highlight its potential for integration into various healthcare applications, offering convenience and accessibility. However, some concerns exist regarding the accuracy and reliability of such technology in real-world clinical settings compared to traditional medical devices.

Overall: Mixed

Strengths

  • Non-contact vital sign measurement (HR, RR, SpO2, BP, stress level)
  • AI-powered computer vision technology
  • Easy integration into existing apps/systems via SDK
  • Potential for remote patient monitoring and telehealth
  • Convenient and user-friendly interface
  • Supports multiple platforms (iOS, Android, Web, Windows, Linux)

Limitations

  • Accuracy concerns compared to medical-grade devices
  • Reliance on good lighting and camera quality for optimal performance
  • Potential for privacy issues with video data
  • Limited independent clinical validation studies publicly available
  • May not be suitable for critical care scenarios
  • Ethical considerations around AI in healthcare diagnostics

Based on reviews from: FaceHeart Official Website, Healthcare IT News articles, Tech review sites (general AI/health tech), Academic papers on rPPG technology, Industry reports on remote patient monitoring, Developer forums discussing SDK integration

Last updated: 2026-07-21

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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

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