Digital health company Mindset Medical has received US Food and Drug Administration (FDA) 510(k) clearance for its contactless pulse rate measurement device, the Informed Vital Core (IVC) App.
This is Mindset Medical’s first FDA clearance. It follows the company’s undisclosed Series A financing announcement in June 2024.
IVC App’s FDA clearance will allow healthcare professionals to collect pulse rate physiological measurements in a patient’s home. Patients can use their devices like smartphones, tablets, or laptops, to facilitate this process.
This device enables physicians to gather basic health data easily, whether in offices, hospitals, clinics, long-term care settings, or at patients’ homes.
Mindset Medical chairman and CEO Mitch Foster said: “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.”
Phoenix, Arizona-based Mindset Medical plans to expand the IVC App to include additional physiological measurements.
However, it is not meant to replace wearables or in-person visits but rather to enhance access to critical health data via smartphones.
With physician and nursing shortages and an ageing population, the digital health company aims to offer significant benefits for patients and providers. It seeks to enable care at home or outside the traditional office setting using only smartphones.
Mindset Medical was formed by several members of robotic surgical platform Excelsius Surgical. The company has developed proprietary signal-processing algorithms that extract health data from video.
Using artificial intelligence (AI) technology for advanced image analysis and facial recognition, these algorithms turn patients’ smartphones into contactless vital sign measurement devices.
Mindset Medical ensures secure, encrypted links via SMS text messaging from healthcare providers to collect real-time patient data and accurate remote physiological measurements.
In 2021, the digital health firm secured a seed investment from Amgen Ventures. However, the financial details and terms of the funding were not disclosed.
