FDA OKs PanopticAI’s Mobile App for Contactless Vital Signs Monitoring

Hong Kong-based startup PanopticAI has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its contactless vital signs monitoring software.

According to the company, the PanopticAI Vital Signs app is the first FDA-cleared mobile app for contactless pulse rate measurement that uses iPhone and iPad’s built in cameras. The company also holds the claim to fame as the first Hong Kong-based company to win an FDA nod for a Software as a Medical Device (SaMD).

The technology turns smartphones and tablets into medical-grade vital signs monitors by leveraging the company’s proprietary, remote photoplethysmography (rPPG) algorithms. Artificial intelligence (AI) and signal processing analyze subtle color changes in skin captured by the device’s camera to measure vital signs like pulse rate in 30 seconds.

PanopticAI believes leveraging smartphone ubiquity for its technology will significantly lower costs and broaden access to vital signs monitoring because it removes the need for specialized equipment.

The company conducted clinical testing based on U.S. census data so validate the app for a diverse patient population. Non-clinical testing also assessed how the app performed under different lighting, distances, and user characteristics. The company said the app was also  subject to cybersecurity and human factors testing.

“We are delighted to receive FDA clearance for our technology, validating our commitment to developing clinically sound, accessible health solutions,” said Dr. Kyle Wong, co-founder and CEO 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.”

The company advised that its app isn’t meant to be the only method to evaluate physical health condition—its measurements should complement but not replace professional care and/or medication.

Artificial intelligence and machine learning promise to transform healthcare delivery, but there are still limits to its capabilities. For now.