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PanopticAI, a pioneer in contactless vital signs monitoring, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its respiratory rate measurement technology, marking another milestone in the company’s efforts to advance smartphone-based health monitoring.
The clearance represents PanopticAI’s second Class II FDA clearance as a software-as-a-medical-device (SaMD), following its earlier approval for pulse rate measurement. As a result, the company’s PanopticAI Vital Signs app becomes the only mobile application with FDA clearance for measuring both pulse rate and respiratory rate using a standard camera, without the need for wearables, sensors, or additional hardware.
The latest regulatory achievement further strengthens PanopticAI’s position in camera-based physiological monitoring. Designed for use in both clinical and home environments, the technology enables healthcare providers and patients to measure vital signs remotely through a smartphone or compatible device.
“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 and 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) technology and advanced motion analysis algorithms. By analyzing subtle physiological signals captured through facial video, the system can accurately measure respiratory activity without direct physical contact.
According to the company, clinical validation studies demonstrated strong performance against reference instruments, meeting the requirements necessary for FDA Class II medical device clearance.
The announcement comes alongside another development for the Hong Kong-based health technology company. PanopticAI has been selected for funding support under the Research, Academic and Industry Sectors One-Plus (RAISe+) Scheme, a major government-backed initiative aimed at helping university research teams commercialize innovative technologies.
The company noted that the support reinforces confidence in the commercial potential of its contactless health monitoring platform as it continues to expand its capabilities.
Looking ahead, PanopticAI is advancing additional physiological measurements within its pipeline. Beyond pulse rate and respiratory rate, the company is developing technologies focused on blood pressure monitoring, atrial fibrillation detection, and assessments related to elevated glucose and lipid risks.
By transforming everyday smartphones into medical-grade health management tools, PanopticAI aims to support a range of healthcare applications, including telecare, remote patient monitoring, elderly care, and population health initiatives. The company believes that making clinical-grade monitoring more accessible and scalable could help healthcare organizations reduce operational burdens while improving access to timely health insights for patients worldwide.
As technologies such as contactless vital signs monitoring continue to advance, conversations around digital health, remote patient monitoring, and AI-powered healthcare solutions remain at the forefront of industry discussions. These topics will be explored further at MedTech World Asia 2026, taking place from August 26–28 at the Hong Kong Convention and Exhibition Centre (HKCEC) in Hong Kong, where healthcare leaders, innovators, investors, and policymakers will gather to examine emerging trends, challenges, and opportunities across the global healthcare ecosystem.
