StethoMe

Company overview

StethoMe is a Poznań, Poland medical device company founded in 2015 and led by co-founder and CEO Paweł Elbanowski. It combines acoustic research, connected hardware and artificial-intelligence algorithms for respiratory-sound assessment.

Its system pairs a wireless electronic stethoscope with a mobile application that guides recordings, analyses breathing sounds and allows users to share recordings and examination history with clinicians. European family and professional offerings use the same core device and software platform.

Market positioning differs by region. European materials present a CE-marked medical-device system for respiratory assessment, while the U.S. website promotes a waitlist for a breathing-score product and explicitly says it is not intended to diagnose, treat, cure, monitor or prevent disease. The European medical claims should not be carried over to the U.S. offering.

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Products & regulatory status How does MedTechIndex get this information?

Summary

StethoMe’s European materials identify its stethoscope and AI algorithms as CE-certified medical devices. The software supports respiratory-sound assessment; it should not be described as establishing a specific disease diagnosis independently of a clinician. ^[4][6][2]

The U.S. site uses a separate breathing-score and waitlist proposition and expressly disclaims medical diagnostic and treatment purposes. European certification does not establish U.S. FDA clearance for those medical claims. ^[4][6][2]

Regulatory snapshot How to read this snapshot

U.S. FDA

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510(k) clearances

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De Novo grants

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PMA approvals

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Recall events

Latest recorded source review: 2026-11-05.

Scope: selected product families.

Commercial portfolio snapshot

Documented commercial product families.

Wireless electronic stethoscope and respiratory analysis software

StethoMe smart stethoscope and analysis platform ↗

Connected stethoscope and app for recording breathing sounds, guiding examination quality and sharing results. European medical-device functionality and the differently positioned U.S. breathing-score offering have distinct claims. ^[6]

European medical-device offering · U.S. offering on waitlist