FDA OKs Mindset Medical’s Contactless Pulse Rate Measurement

Mindset Medical, a digital health company, has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Informed Vital Core (IVC) app. The contactless pulse rate measurement device represents the company’s first FDA clearance, following a June Series A financing round.

The IVC app lets healthcare professionals collect pulse rate measurements in a patient’s home using their own smartphone, tablet, or laptop. In addition to the home, Mindset Medical believes the app can ease collection of basic health information in or out of the office, hospitals, clinics, and long-term care settings.

The app works by leveraging a neural network to divide the patient’s face into measurement zones. Remote photoplethysmoraphy (rPPG) tech detects subtle changes in skin color as blood flows through the face, and those changes are processed into waveforms. Those waveforms then deliver physiological measurements to the physician or care team.

The company plans to broaden the application to include other physiological measurements assuring that it doesn’t intend to replace wearables or in-person visits. Mindset Medical said it hopes to expand access to crucial physiological information where patients can use their smartphones.

The company also said it developed this device to mitigate nursing shortages and meet the challenges of an aging population, and sees meaningful benefits for patients and providers by using a smartphone for home care and away from traditional provider offices.

“Mindset Medical is passionate about delivering meaningful healthcare applications to the patient’s home using the most ubiquitous device – their smartphone,” Mindset Medical chairman and CEO Mitch Foster told the press. “This technology helps deliver health equity by potentially removing many barriers that patients and providers face regularly.”