The software-as-a-medical-device allows for contactless measurement of respiratory and pulse rates using only a standard smartphone camera.
RT’s Three Key Takeaways:
- Contactless Monitoring: PanopticAI has received USFDA 510(k) clearance for its camera-based respiratory rate measurement tool, which requires no external sensors, wearables, or accessories.
- Dual Vital Signs: The software is now the only mobile application cleared for both pulse and respiratory rate monitoring using a standard camera, according to the company.
- Clinical Validation: The technology uses motion analysis and remote photoplethysmography to detect physiological signals from facial video, meeting FDA requirements for accuracy against reference instruments.
PanopticAI has received USFDA 510(k) clearance for its contactless respiratory rate measurement, according to the company. This marks the second Class II FDA clearance for the company’s software-as-a-medical-device platform, following its previous clearance for pulse rate monitoring.
The PanopticAI Vital Signs app operates using a standard camera to monitor core vitals without external sensors or hardware, enabling contactless monitoring in both clinical and home settings. The company stated that the app is currently the only mobile software cleared for two core vital signs using only a camera.
“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 Kyle Wong, ceo and co-founder of PanopticAI, in a news release. “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 utilizes proprietary remote photoplethysmography (rPPG) and motion analysis algorithms to detect 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, according to the news release.
The company is also advancing a pipeline of additional contactless measurements, including blood pressure, atrial fibrillation, and the risk of elevated glucose and lipids. By using smartphones as medical-grade tools, the technology is intended to “transform” telecare, remote patient monitoring, elderly care, and population health programs to make monitoring more accessible and scalable.
The company also announced it was selected for funding support under the Research, Academic and Industry Sectors One-Plus (RAISe+) Scheme. This Hong Kong government grant program supports university research teams in shifting innovations into startups.
According to the company, the Vitals SDK can measure physiological parameters in less than 25 seconds. This technology is intended to help healthcare providers, wellness organizations, and insurance enterprises reduce the burden on healthcare staff while providing users with data for early detection and chronic disease management.
https://www.prnewswire.com/apac/news-releases/fda-clears-panopticais-contactless-respiratory-rate-measurement-302806032.html 22 Jun, 2026, 11:49 CST
