FaceHeart offers a SDK that utilises a smartphone's camera to capture vital signs – including heart rate, respiratory rate, blood pressure, oxygen saturation, and heart rate variability – and measure them within 50 seconds.
It does this using computer vision, rPPG (remote photoplethysmography), and deep learning.
Citing FDA's evaluation, the company shared that its SDK's respiratory rate component demonstrated consistent deviations within ±2 breaths per minute across devices.
This FDA approval is the company's second following the 510(k) clearance for the heart rate component of the FaceHeart SDK in 2023.
The Taiwanese company's SDK can be integrated into common edge devices, such as smartphones, tablets, and desktop or laptop computers, and conducts analysis using edge computing without a cloud service to maintain security and eliminate network latency.
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