#USA #Phoenix #FDA #Telehealth #Mindset Medical

Mindset Medical Achieves FDA Clearance for Innovative Device

Mindset Medical, Inc., a digital health company based in Phoenix, has officially announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its latest medical technology—the Informed Vital Core (IVC) App. This groundbreaking app is designed specifically for contactless monitoring of patients’ respiratory rates using everyday technology such as smartphones, tablets, or laptops.

The FDA's 510(k) clearance, granted on June 4, 2025, represents Mindset Medical's second major milestone in less than a year, following its previous clearance for a pulse rate measurement device last November. With this new development, the company is poised to make waves in the telehealth industry, furthering its mission to enhance healthcare delivery through innovative technology.

A Step Forward in Telehealth

This new device offers healthcare providers a much-needed solution for gathering vital signs without the need for physical contact or specialized hardware. Given the increasing reliance on telemedicine, especially due to changing healthcare landscapes caused by the COVID-19 pandemic, the ability to use standard devices already in patients’ homes for vital sign monitoring is a game-changer. Telehealth has seen a significant surge, overcoming past barriers of adoption and integrating video conferencing into routine health assessments.

Mitch Foster, Chairman and CEO of Mindset Medical, emphasized the importance of evolving virtual healthcare: “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.” He believes that the future of healthcare will blend physical and virtual experiences, making for a more accessible and effective system.

Bridging Gaps in Access

The vision for Mindset Medical extends beyond just respiratory monitoring. The company is committed to integrating various vital sign measurements into its platform, targeting a future where diagnostics can be achieved using simple, widely available technology. This would potentially bridge gaps in healthcare access, alleviating pressure on providers and allowing for earlier intervention in patient care.

Mindset Medical’s innovation comes from a unique marriage of technological prowess and healthcare insight. They have developed proprietary algorithms that leverage AI and advanced image analysis to derive physiological measurements from video. By transforming smartphones into contactless vital sign measurement tools, they are setting a new standard in digital health monitoring.

A Bright Future for Digital Health

Headquartered in Arizona, Mindset Medical aims to continue advancing its platform to include an array of physiological measurements, all while maintaining close collaboration with healthcare professionals and patients. This approach ensures that every new feature added to their offering directly aligns with the real needs of users, enhancing the overall quality of care.

As Mindset Medical forges ahead, its commitment to innovation and accessibility in healthcare represents a forward-thinking approach that many in the industry will be watching closely. The recent FDA clearance is not merely a regulatory victory; it signifies a substantial stepping stone toward a future where healthcare is more integrated, efficient, and ultimately more humane. The landscape of telehealth is evolving rapidly, and Mindset Medical is undeniably at the forefront of this transformation.

For more information about Mindset Medical and their revolutionary technology, you can visit their website at mindsetmedical.com. With their focus on leveraging everyday technology, Mindset Medical is paving the way for innovative healthcare solutions that could redefine the patient experience in the years to come.