FaceHeart from Taiwan has obtained regulatory approval in the United States for its AI-driven contactless technology for measuring respiratory rate.
It obtained a 510(k) clearance from the US Food and Drug Administration for the respiratory rate measurement component of its software development kit.
WHAT IT’S ABOUT
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. The technology has use cases in preventive health, telemedicine, elderly care, and chronic disease management.
MARKET SNAPSHOT
Several smartphone-based applications that utilise PPG signals to gauge vital signs have also come to the market in recent years. Noteworthy among them is Google Fit. In Asia-Pacific, notable players include MFine from India and listed company Advanced Health Intelligence (formerly Advanced Human Imaging) from Australia.
The National Taiwan University Hospital in Taiwan and its partner, FocalTech Smart Sensors Co., also developed a mobile app that measures heart rhythm by scanning a user’s fingertip via a smartphone camera.
Meanwhile, Canadian company NuraLogix’s Anura vital signs measurement app has been made available in Singapore.
Another popular use of smartphone cameras for health screening is to detect and predict stroke, such as the inventions of Penn State University and Houston Methodist Hospital in the United States and RMIT University in Australia.
