FaceHeart Vitals Software Development Kit (FH vitals SDK)
FaceHeart Corp.The FaceHeart Vitals Software Development Kit (FH vitals SDK) is an AI-based software that measures pulse rate from facial video streams using standard cameras on mobile devices or computers. It provides non-invasive, real-time pulse rate monitoring for adults at rest, intended to assist healthcare professionals but not to replace critical care or continuous monitoring. The SDK uses face recognition and signal processing algorithms to produce accurate pulse rate measurements, helping clinicians monitor patient heart rate remotely or in general healthcare settings.
Intended Use
Designed to measure pulse rate non-invasively from facial video streams as spot measurements when the subject is still; indicated for humans 18 years or older not requiring critical care or continuous monitoring; not intended for patients with arrhythmias or as a sole health assessment.
Technology
The software runs on commercial mobile devices/computers with cameras, analyzes video of the user's face to measure pulse rate by signal processing algorithms. It requires stationary conditions and may use accelerometer data when available. Compatible with Windows 10, Android 12, and iOS 12, and various standard cameras.
Performance
Clinical testing on 527 diverse adult subjects showed pulse rate measurement accuracy within ±3 bpm compared to Philips MX100 ECG, with approximately 93.8% agreement. Non-clinical software testing verified device compatibility, functionality, motion impact, and real-time processing performance on multiple devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/5/2022
9 months - 2
FDA Approval
9/1/2023
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