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

PHOENIX, June 4, 2025 /PRNewswire/ — Mindset Medical, Inc. (“Mindset Medical” or the “Company”), a digital health company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its latest contactless vital sign monitoring solution. The Informed Vital Core (IVC) App is a software-only medical device that measures respiratory rate through smartphones, tablets, or laptop cameras.

This milestone marks Mindset Medical’s second FDA clearance in less than a year, building on the success of its previously cleared pulse rate measurement device on November 18, 2024. With these clearances, Mindset Medical is closer to transforming the delivery of care with innovative telehealth technology.

Mindset Medical can now offer another solution for healthcare providers to gather physiological information from their patients without needing physical contact or dedicated hardware. Software on phones, tablets, and laptops can easily be deployed in clinical and outpatient facilities, remote care environments, long-term care settings, or the patient’s home. Telemedicine skyrocketed due to COVID-19, as many barriers to adoption were removed, allowing video conferencing to become routine.

“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.”
— Mitch Foster, Chairman and CEO of Mindset Medical.

Mindset Medical envisions a future where vital signs and diagnoses can be captured with nothing more than everyday devices. This will help bridge gaps in access to healthcare, reduce the burden on providers, and improve chances for earlier intervention.

The company continues developing its platform to include additional vital sign measurements, working closely with clinicians and patients to ensure each new feature meets their needs.

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 to patients from healthcare providers to collect up-to-the-minute patient data and accurate remote physiological measurements.

Contact

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#healthcare #telehealth #healthequity #vitals #physiological

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SOURCE Mindset Medical, Inc.