World’s First Mobile App for Contactless Pulse Rate Measurement

The world’s first FDA-cleared mobile application for contactless pulse rate measurement, using the built-in camera of iPhones and iPads has launched ( January 2025). This also distinguishes the PanopticAI Vital Signs app as the first Hong Kong-based company to achieve FDA clearance for Software as a Medical Device (SaMD).

PanopticAI, is a leading innovator in remote patient monitoring and with this announcement had received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its contactless vital signs monitoring software (January,2025).

PanopticAI’s technology leverages proprietary remote photoplethysmography (rPPG) algorithms to transform readily available smartphones and tablets into medical-grade vital sign monitors. Advanced AI and signal processing techniques are used to analyse subtle colour changes in the skin captured by the device’s camera, accurately measuring vital signs like pulse rate in just 30 seconds. This FDA clearance represents a significant milestone in PanopticAI’s mission to make healthcare more accessible and scalable.

PanopticAI’s solution eliminates the need for specialist equipment by utilizing cellphones’ widespread availability, drastically lowering costs and providing access to vital sign monitoring to a larger audience. Hospitals, insurance companies, and pharmacies are already using the company’s contactless vital signs monitoring technology.

Its clients include Gleneagles Hospital Hong Kong (part of IHH Healthcare, one of the world’s top healthcare providers), Mannings (Hong Kong’s major health and beauty chain), and Bupa (a worldwide health insurer). Clinical testing was undertaken on a diverse patient group based on US census data to assure the PanopticAI Vital Signs app’s accuracy and reliability across a wide spectrum of users. Rigorous non-clinical testing examined the app’s performance in numerous settings, including varying lighting, distances, and user characteristics.

The PanopticAI Vital Signs app also underwent rigorous cybersecurity and human factors testing to ensure patient safety and ease of use. “We are delighted to receive FDA clearance for our technology, validating our commitment to developing clinically sound, accessible health solutions,” said Dr. Kyle Wong, CEO & Co-founder of PanopticAI. “This clearance for contactless pulse rate measurement is the first of several anticipated approvals, and we look forward to building upon this success as we expand our technology’s capabilities.”