Taiwanese AI Company Obtains 510(k) for Video-Based Respiratory Rate Gauge

Taiwanese AI company FaceHeart has received regulatory approval in the United States for its contactless technology that measures respiratory rate using a smartphone camera. The company secured 510(k) clearance from the US Food and Drug Administration (FDA) specifically for the respiratory rate measurement component of its software development kit (SDK), marking its second FDA approval following the clearance of the SDK’s heart rate feature in 2023. The FaceHeart SDK leverages computer vision, remote photoplethysmography (rPPG), and deep learning algorithms to capture and analyze vital signs—including heart rate, respiratory rate, blood pressure, oxygen saturation, and heart rate variability—within just 50 seconds using the built-in camera on smartphones and other common devices.

According to the FDA’s evaluation, the respiratory rate component demonstrated consistent performance across devices, maintaining deviations within ±2 breaths per minute, which supports its reliability for clinical and wellness applications. The SDK is designed to integrate with edge devices such as smartphones, tablets, desktops, and laptops, enabling real-time analysis directly on the device itself. By relying on edge computing rather than cloud services, FaceHeart ensures user data privacy, eliminates network latency, and enhances the speed and security of health assessments. This approach makes the technology particularly suitable for telemedicine, preventive healthcare, chronic disease monitoring, and elderly care, where accessibility, efficiency, and data protection are critical.

FaceHeart’s approval comes at a time when smartphone-based health monitoring tools are gaining traction globally. Several apps utilizing photoplethysmography (PPG) signals for vital sign measurement have emerged in recent years. Google Fit, for example, offers basic health tracking capabilities using smartphone cameras, while in the Asia-Pacific region, companies like India’s MFine and Australia’s Advanced Health Intelligence (formerly Advanced Human Imaging) have developed similar technologies. Taiwan has also been active in this space, with National Taiwan University Hospital and FocalTech Smart Sensors Co. collaborating on a mobile app that uses a smartphone camera to scan a fingertip and detect heart rhythm abnormalities. Additionally, Canada’s NuraLogix has introduced its Anura app in Singapore, offering facial video-based vital sign analysis as part of its health screening capabilities.

Beyond vital sign monitoring, smartphone cameras are increasingly being used to detect and predict serious medical conditions such as stroke. Research institutions including Penn State University and Houston Methodist Hospital in the United States, as well as RMIT University in Australia, have developed camera-based tools that can screen for stroke risk or identify signs of stroke in real time. FaceHeart’s recent FDA clearance positions it among these emerging innovators using consumer devices and advanced algorithms to make health monitoring more accessible, non-invasive, and secure.