FDA Clears PanopticAI's Contactless Respiratory Rate Measurement
Following the startup's first FDA 510 (k) clearance for its contactless pulse rate monitoring, PanopticAI has now secured a second one for respiratory rate measurement. This milestone cements its position as the world leader in camera-based physiological measurement, bringing the industry closer to a future where clinical-grade health monitoring is accessible to anyone with a smartphone.
HONG KONG, June 22, 2026 /PRNewswire/ -- 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. PanopticAI 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.
About PanopticAI
PanopticAI is Hong Kong's leading health technology company revolutionizing vital signs monitoring with its FDA-cleared remote photoplethysmography (rPPG) technology. Our award-winning Vitals SDK transforms smartphones, tablets, and computers into medical-grade vital signs monitors, making health monitoring accessible and scalable for everyone. In less than 25 seconds, Vitals SDK accurately measures key physiological parameters, including heart rate, heart rate variability, breathing rate, oxygen saturation, blood pressure, stress level and more - all without wearables or specialized equipment. This breakthrough in remote patient monitoring enables healthcare providers, wellness organizations, and insurance enterprises to reduce the burden on healthcare staff while empowering users with insights for early detection and chronic disease management.
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SOURCE PanopticAI
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