App that uses iPhone to monitor vital signs receives FDA clearance

PanopticAI has received 510(k) clearance from the 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.

The app uses proprietary algorithms to turn 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, according to the company.

The 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.

Clinical testing was conducted on a diverse patient population reflecting US census data to ensure the accuracy and reliability of the app across a broad range of users. 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.

"We are delighted to receive FDA clearance for our technology, validating our commitment to developing clinically sound, accessible health solutions," said 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."

Chibo Tang, managing partner of Gobi Partners, a financial backer of the company, said, "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 health care journeys."