Mindset Medical has received US Food and Drug Administration (FDA) 510(k) clearance for its contactless respiratory rate measurement device, the Informed Vital Core (IVC) App.
The software-only medical device uses cameras on smartphones, tablets, and laptops to measure respiratory rates, marking a significant advancement in telehealth technology.
It is Mindset Medical’s second FDA clearance within a year, following the approval of its pulse rate measurement device on 18 November 2024.
The IVC App can be deployed in various settings, including clinical and outpatient facilities, remote care environments, long-term care settings, and patients’ homes.
Mindset Medical aims to make vital signs and diagnoses captured using everyday devices, enhancing healthcare access and reducing the burden on providers.
The company is also expanding its platform to include additional vital sign measurements, collaborating with clinicians and patients to ensure new features meet their needs.
Mindset Medical chairman and CEO Mitch Foster said: “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.
“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.”
Based in Phoenix, AZ, Mindset Medical was founded by members of Excelsius Surgical, a robotic surgical platform.
It has developed proprietary signal-processing algorithms that extract health measurements from video, combined with AI technology for advanced image analysis and facial recognition.
The innovations transform smartphones into contactless vital sign measurement devices, using secure and encrypted links to deliver real-time patient data to healthcare providers.
