FDA OKs Mindset Medical’s Contactless Respiratory Rate Measurement

Digital health company Mindset Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its latest contactless vital sign monitoring device, the Informed Vital Core (IVC) app.

The IVC app is a software-only medical device that measures respiratory rate using smartphones, tablets, or laptop cameras. This is Mindset Medical’s second FDA nod in under a year—its pulse rate measurement device was cleared in November 2024.

The app is another tool to gather physiological information from patients without physical contact or dedicated hardware. Software for phones, laptops, and tablets can easily be used in clinical and outpatient facilities, remote or long-term care settings, or the home.

Telemedicine flourished because of COVID-19 because many barriers to adoption were eliminated, letting video conferencing become routine. Mindset Medical said it hopes for a future where vital signs and diagnoses can be gathered with everyday devices.

“Video alone is not enough. Patients and providers deserve virtual services with fewer barriers and limitations because we are all patients at the end of the day,” said Mindset Medical’s chairman and CEO Mitch Foster. “The next step is purpose-built virtual health offerings that can legitimately provide brick-and-mortar experiences. Virtual healthcare remains a permanent fixture moving forward, and we have only scratched the surface of how we use technology to address shortcomings with the health system.”