Mindset Medical Announces FDA Clearance for its Contactless Pulse Rate Measurement Device

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Mindset Medical, Inc. (“Mindset Medical” or the “Company”), a digital health company, today announced FDA 510(k) clearance for its contactless pulse rate measurement device, the Informed Vital Core (IVC) App. This clearance is Mindset Medical's first and is a significant accomplishment following the announcement of Series A financing on June 6, 2024.

This clearance for the IVC App is unique as it allows healthcare professionals to collect pulse rate physiological measurements in a patient’s home using their own devices, such as a smartphone, tablet, or laptop. The IVC App makes it easier for physicians to collect basic health information in or out of the office, hospitals, clinics, long-term care settings, and the patient’s home.

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

The vision is to extend this application to include other physiological measurements in the future, not to replace wearables and in-person office visits but to expand access to this critical information wherever the patient can use their smartphone. As physician and nursing shortages increase along with the aging population, Mindset Medical sees meaningful benefits for both patient and provider by using the patient’s smartphone for care at home and away from the traditional provider office.

About Mindset Medical

Mindset Medical, Inc. (mindsetmedical.com), headquartered in Phoenix, AZ, was formed by several members of Excelsius Surgical, a robotic surgical platform. Recently, Mindset Medical has developed proprietary signal-processing algorithms that extract health measurements from video. Combined with AI technology for advanced image analysis and facial recognition, these algorithms transform patients’ smartphones into contactless vital sign measurement devices. Mindset Medical utilizes secure and encrypted links delivered by SMS text messaging from healthcare providers to collect up-to-the-minute patient data and accurate remote physiological measurements.

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