(Hong Kong, 26 January 2025) - PanopticAI, a leading innovator in remote patient monitoring, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its contactless vital signs monitoring software. The PanopticAI Vital Signs app is the first FDA-cleared mobile application for contactless pulse rate measurement using the built-in camera of iPhones and iPads. This also distinguishes PanopticAI as the first Hong Kong-based company to achieve FDA clearance for a Software as a Medical Device (SaMD).
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 analyze subtle color 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. By leveraging the ubiquity of smartphones, PanopticAI's technology eliminates the need for specialized equipment, significantly reducing costs and expanding access to vital sign monitoring for a wider population. The company's contactless vital signs monitoring technology is already used by hospitals, insurance providers and pharmacies. Its customers include Gleneagles Hospital Hong Kong (part of IHH Healthcare, one of the world's largest healthcare providers), Mannings (Hong Kong's leading health and beauty chain) and Bupa (multinational health insurer).
Clinical testing was conducted on a diverse patient population reflecting US census data to ensure the accuracy and reliability of the PanopticAI Vital Signs app across a broad range of users. Rigorous non-clinical testing evaluated the app's performance under various conditions, including different lighting, distances, and user characteristics, to ensure reliable operation in real-world settings. 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."
Dr. Kenneth Tsang, Chief Executive Officer of Gleneagles Hospital Hong Kong (Gleneagles) and Regional Chief Executive Officer of IHH Healthcare North Asia, said, "Gleneagles embraces innovative solutions and new technologies to make personalised healthcare more accessible and encourage patients to have better awareness and management of their own health and wellbeing. As the first private hospital in Hong Kong to collaborate with PanopticAI to adopt the solution in the hospital's mobile application, we are pleased to be able to help more patients through participating in the validation of the reliability and effectiveness of this innovative technology."
Chibo Tang, Managing Partner of Gobi Partners, said, "Gobi Partners were early supporters of PanopticAI and are excited by this important milestone. Traditional vital sign monitoring wearables are often costly and uncomfortable, leading to poor adherence. PanopticAI's FDA-cleared app, however, makes monitoring your vital signs as easy as using your smartphone, empowering patients to become active participants in their own healthcare journeys."
The PanopticAI Vital Signs app is not intended to be the sole method to assess a subject's physical health condition. The measurements it provides should complement, not replace, professional medical care and/or medication.
