Mindset Medical, Inc., a digital health company, today announced that it has received FDA 510(k) clearance for its contactless pulse rate measurement device, the Informed Vital Core (IVC) App. This marks the company’s first FDA clearance and is a major achievement following their Series A financing announcement on June 6, 2024.
Mindset Medical, Inc., a digital health company, has announced the FDA 510(k) clearance for its innovative Informed Vital Core (IVC) App. This clearance represents a groundbreaking achievement for the company as it enables healthcare professionals to collect pulse rate measurements remotely from a patient’s home using their own personal devices, such as smartphones, tablets, or laptops. The IVC App is a versatile tool that simplifies the collection of essential health data, whether in a doctor’s office, clinic, hospital, long-term care facility, or even within the comfort of the patient’s home.
With this clearance, Mindset Medical aims to address critical issues in healthcare delivery, including accessibility and convenience. Mitch Foster, Chairman and CEO of Mindset Medical, expressed the company’s commitment to using ubiquitous technology to bring healthcare to the patient’s doorstep. “Mindset Medical is passionate about delivering meaningful healthcare applications to the patient’s home using the most ubiquitous device – their smartphone,” said Foster. “This technology helps deliver health equity by potentially removing many barriers that patients and providers face regularly.”
The IVC App is not designed to replace traditional wearables or in-person doctor visits, but instead to enhance access to health data by allowing physicians to gather vital measurements outside the clinic setting. This is particularly important as physician and nursing shortages rise, and as the global population continues to age. Mindset Medical envisions its technology as a solution that helps bridge the gap in healthcare access, offering more flexible and efficient care both at home and away from the traditional office setting.
The company’s goal is to expand the capabilities of the IVC App to include additional physiological measurements in the future. This expansion would allow healthcare providers to monitor a wider range of health indicators remotely, giving them real-time data on patients’ health status without the need for direct in-person visits. This, in turn, could help reduce hospital visits and the strain on healthcare systems, while improving the quality of care by enabling more proactive management of patient health.
Founded by several members of Excelsius Surgical, a robotic surgical platform, Mindset Medical specializes in developing cutting-edge healthcare technologies. The company has developed proprietary signal-processing algorithms that extract vital health measurements from video, using advanced AI for image analysis and facial recognition. These technologies turn patients’ smartphones into contactless vital sign measurement devices, revolutionizing the way health data is collected.
Mindset Medical’s secure system leverages encrypted links sent via SMS text messaging from healthcare providers, enabling the collection of up-to-date patient data and accurate remote physiological measurements. This system ensures that patient information remains private and secure, addressing concerns related to data security in the digital health space.
In summary, the FDA clearance of the IVC App marks a significant milestone for Mindset Medical, positioning the company as a leader in the field of digital health. By empowering healthcare providers to remotely collect vital signs through easily accessible technologies, Mindset Medical is helping to pave the way for more accessible, equitable, and efficient healthcare for patients everywhere.
