Medaica M1 stethoscope

Medaica M1 Telehealth Stethoscope and Platform Receives FDA Clearance

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We’re proud to announce that Medaica has received clearance from the U.S. Food and Drug Administration (FDA) for our M1 Telehealth Stethoscope and software platform.

The M1 and platform are cleared for over-the-counter (OTC) use, bringing heart and lung exams into the home, without the need for a clinic visit.

The M1 pairs with Medaica’s telehealth platform to guide users through a remote heart or lung exam. Its patented technology enables high-quality auscultation sounds to be captured during telehealth sessions, with virtual positioning to help ensure accurate placement. The clinical-grade auscultation sounds are securely transmitted to a healthcare professional for review with assisted AI diagnostic support tools. The result is remote auscultation that’s simple, affordable, and accessible, especially for the more than 50 million Americans who live over an hour from a doctor.

For too long, telehealth has been limited to conversations. With M1, it helps to bring healthcare into the home.

“Medaica was built on a simple idea: give people better access to meaningful health insights, earlier,” said Stephen Randall, CEO of Medaica. “Our technology unlocks at-home exams for patients to receive convenient and effective care remotely. 

As we expand access to at-home exams, we’re building toward a future where earlier detection is easier, more affordable, and available to everyone. Because when conditions are identified early, intervention can have the greatest impact.

Detect early. Act early.