FaceHeart Inc. announced that its FaceHeart Vitals™ SDK heart rate measurement software has been officially approved by the FDA as Class II SaMD on 1 September, 2023, making it the world's first product to use a general lens to measure heart rate and obtain FDA certification. It only requires a single video camera of handheld devices to obtain physiological information, which can then be quickly introduced into telemedicine, elderly care, remote patient monitoring and other scenarios.

In addition, FaceHeart also continues to work on the FDA and EU clearance for the measurement of physiological information such as respiration, blood oxygen, and blood pressure, thus accelerating the expansion of its services to the cross-border smart healthcare market.

FaceHeart Vitals™ uses the image-based non-contact rPPG (Remote Photoplethysmography) technology to analyse the subtle colour changes of the face down to the pixel level by detecting and analysing the image, and with the development of AI learning models, users can obtain physiological information such as heart rate, heart rate variability, blood pressure, blood oxygen, respiratory rate and pressure within 60 seconds by using a smartphone front lens or tablet video lens at the face. It can be flexibly applied to different hardware devices and service scenarios by means of software development kits.

As of September 2023, FaceHeart has been cooperating with the cardiology departments of National Taiwan University Hospital, Chang Gung Memorial Hospital, Taipei Veterans General Hospital, En Chu Kong Hospital, and hospitals in the US to conduct clinical tests, with a total of more than 4,000 participants and 150 million of data sets obtained. Combining the clinicians' diagnosis and AI learning optimisation, the six main types of accurate physiological information data can be generated through non-contact, camera lens and rapid information output. It is highly suitable for the development of precision medical applications.

Currently, FaceHeart has been applied to telemedicine, elderly care, remote patient monitoring, health app platforms, and in partnership life insurers, etc. It is hoped FaceHeart can accelerate the promotion of its services cross borders and different application scenarios with its FDA-approvde SaMD.