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Medical Devices & Diagnostics

Withings BeamO can now send heart sounds to FDA-cleared AI for murmur analysis

Withings has introduced StethO Sense, a new Withings+ service that applies artificial-intelligence analysis to heart and lung recordings captured by the company’s BeamO connected health device. BeamO itself is FDA cleared and combines a clinical-grade thermometer, single-lead ECG and digital stethoscope in a handheld product. StethO Sense adds analysis from eMurmur Heart AI for heart sounds and StethoMe for respiratory-sound patterns, with commercial availability scheduled to begin October 1.

The regulatory distinctions within the service are important. eMurmur Heart AI is FDA cleared for use in adults and children and is intended to assist healthcare professionals, while the StethoMe Breathing Index offered in the United States is a general-wellness feature and is explicitly not FDA cleared for diagnosing or treating respiratory disease. Withings also states that BeamO and StethO Sense are intended to complement professional evaluation rather than replace an in-person examination.

How does the heart murmur analysis work with BeamO?

BeamO allows users to record heart sounds through its integrated digital stethoscope and send those recordings into the StethO Sense workflow. eMurmur Heart AI analyzes the recording and can distinguish between no detected murmur, an innocent murmur and an abnormal murmur while also providing heart rate and a confidence score.

The underlying eMurmur technology has been evaluated in prospective clinical studies and has FDA clearance for professional use in both pediatric and adult populations. The result remains diagnosis-assisting rather than autonomous, meaning a clinician is responsible for final assessment and must interpret the finding alongside symptoms, physical examination and other appropriate testing.

What does the breathing feature do and what does it not do?

The StethoMe component generates a Breathing Index scored from zero to 100 based on recorded respiratory sounds and the quality of breathing. The guided protocol uses six recording locations for children and eight for adults, allowing users to track changes in respiratory-sound patterns over time.

In the United States, however, this feature is positioned strictly as general wellness. Withings explicitly states that the StethoMe Breathing Index is not FDA cleared and is not intended to diagnose, treat, cure or prevent disease, nor is it intended as a substitute for medical advice. That is an essential limitation when describing a consumer product that can otherwise sound similar to a clinical respiratory diagnostic.

Why could AI-assisted auscultation become useful outside a clinic?

Heart and lung auscultation traditionally depends on a clinician listening through a stethoscope and recognizing subtle sound patterns. Digital stethoscopes convert those sounds into recordings that can be replayed, shared remotely and analyzed algorithmically. Connecting such recordings to AI potentially creates a way to identify signals that deserve professional attention even when the patient and clinician are not in the same room.

The home setting is particularly interesting because a child’s cough, breathing pattern or intermittent heart sound may not be present during one scheduled appointment. Repeated home recordings could allow families to capture a change when it occurs and share that information with healthcare professionals, although the clinical value depends heavily on recording quality and appropriate interpretation.

Does this mean parents can diagnose a heart murmur at home?

No. Withings specifically frames the technology as supportive rather than substitutive, and eMurmur’s cleared algorithm is diagnosis-assisting for healthcare professional use. A detected abnormality should therefore function as information for a clinician rather than a definitive consumer diagnosis.

This distinction becomes even more important for children because innocent murmurs are common and can sound abnormal to an untrained listener despite not representing structural heart disease. Conversely, a normal recording cannot rule out every cardiac condition, particularly when abnormalities are intermittent or not detectable through auscultation alone.

How is Withings turning BeamO into a subscription platform?

StethO Sense will become part of Withings+, the company’s paid health service, from October 1. Withings says consumers purchasing BeamO for $249.95 will receive a one-month Withings+ trial, after which the subscription costs $9.95 per month or $99.50 annually in the United States.

The commercial model illustrates a broader trend in connected medical devices. Hardware increasingly becomes the data-capture layer, while recurring software services generate interpretation, longitudinal analysis and AI-supported insights. For manufacturers, that can create recurring revenue after the initial device sale; for regulators and users, it also makes clear labeling essential because different software functions running on the same physical device can have very different regulatory statuses.

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