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Medaica Receives FDA Clearance for M1 Telehealth Stethoscope

Consumer stethoscope makes “digital house calls” possible over telehealth

HENDERSON, NV, USA, Jan. 20, 2023 - Medaica, a digital health company, extending the capability of home diagnostics, today announced its Medaica M1 Telehealth Stethoscope has received U.S. Food and Drug Administration (FDA) 510(k) clearance (Note 1).

The Medaica M1 Telehealth Stethoscope (M1) has been cleared for Over-the-Counter (OTC) use by consumers. M1 is a plug-and-play solution for a patient to connect to a doctor, who can then listen to a remote patients’ hearts, lungs, or other organ sounds over a telehealth visit, as easily and clearly as if they were in the same room.

“A medical exam that would otherwise require either an expensive proprietary system or an in-person appointment, can now be a simple and standard feature of any telehealth visit,” said Stephen Randall, CEO of Medaica. “We can make a doctor’s 'digital house call’ something that anyone, anywhere has access to.”

Interoperability with 3rd party telehealth systems is built into the Medaica solution and is becoming a requirement that many healthcare organizations including the American Telehealth Association (Note 2) recognize as fundamental to realizing the full potential of digital health.

The Medaica M1 Telehealth Stethoscope is bundled with a complete end-to-end digital diagnostics and telehealth solution for providers who want the full capability of using M1 for remote auscultation with best-in-class telehealth features, in one integrated solution.

Medaica has been working with several leading hospitals and clinics to support their healthcare initiatives including Emory Hospital, Georgia.

Dr Byron Williams Jr., Emeritus Chief of Medicine at Emory University Hospital commented, “Providing affordable and accessible healthcare solutions to our rural patients is one of our biggest challenges. Medaica’s M1 Telehealth stethoscope enhances our remote care, making it possible for us to conduct post-acute follow-up telehealth exams, resulting in greater efficiencies and more affordable healthcare.”

For more details on how Medaica M1 Telehealth Stethoscope can enhance telehealth offerings, please contact or visit

1. FDA 510(k) Summary:

2. American Telehealth Association: “Telehealth Interoperability” White Paper

About Medaica

Medaica is a digital health company, extending the reach and capability of home diagnostics. The company’s mission is to enable affordable access to quality healthcare for everyone. Medaica’s products include the FDA-cleared Medaica M1 Telehealth Stethoscope and Medaica remote diagnostics and telehealth platform. Medaica is headquartered in Henderson, Nevada, with offices in London and Madrid.

For more information visit www

Medaica and Medaica M1 Telehealth Stethoscope are trademarks of Medaica Inc.

Media Contact:

Stephen Randall,

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