(Hong Kong, 18 June 2026) — PanopticAI, a pioneer in contactless vital signs monitoring, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its respiratory rate measurement. This is the company’s second Class II FDA clearance as a software-as-a-medical-device (SaMD), following its landmark clearance for pulse rate. This means its PanopticAI Vital Signs app is now the only mobile app clinically cleared for two core vital signs using nothing more than a standard camera.
With this latest development, PanopticAI further strengthens its leadership in camera-based physiological measurement, adding another FDA clearance to its software platform. Vital Signs operates without any external sensors, wearables, or accessories, enabling true contactless monitoring in both clinical and home settings.
“FDA clearance for respiratory rate is a major leap forward in our mission to build the world’s first clinical-grade contactless physiological measurement platform that enables accessible health measurement, monitoring, and management on a smartphone,” said Dr. Kyle Wong, CEO & Co-founder of PanopticAI. “Respiratory rate is a critical yet often underutilized vital sign, especially in telehealth and remote patient monitoring. With both pulse and respiratory rates now cleared, we are establishing a new standard for virtual care.”
The respiratory rate feature is powered by PanopticAI’s proprietary remote photoplethysmography (rPPG) and advanced motion analysis algorithms, which detect subtle physiological signals from facial video captured by a camera. In clinical validation studies, the technology demonstrated high accuracy against reference instruments, meeting the rigorous performance requirements for FDA Class II medical device clearance.
The company also announced that it has been selected for funding support under the Research, Academic and Industry Sectors One-Plus (RAISe+) Scheme, the Hong Kong government’s most prestigious university research commercialization grant program. With a funding allocation of $10 billion, the RAISe+ scheme supports high-potential university research teams in transforming their innovations into successful startups, further validating PanopticAI’s potential for large-scale commercial impact.
With the support of its clients, investors, and the Hong Kong government, PanopticAI is rapidly advancing its pipeline of contactless vital sign measurements. In addition to pulse rate and respiratory rate, the company has measurements for blood pressure, atrial fibrillation, and even the risk of elevated glucose and lipids in development. By transforming smartphones into medical-grade health management tools, PanopticAI is poised to revolutionize telecare, remote patient monitoring, elderly care, and population health programs, making clinical-grade monitoring accessible, affordable, and scalable for everyone.
Since 2021, PanopticAI has received comprehensive support from Hong Kong Science and Technology Parks Corporation and successfully completed Ideation and a three-year incubation programme. Its vital signs monitoring solution has been widely adopted by hospitals, insurance companies, and chain retailers—a testament to the capability of local I&T startups in advancing from R&D to commercialisation.
