Withings BeamO Receives FDA Clearance: The Thermometer of the Future Arrives
Withings has long been a leader in connected health, but the company’s newly FDA-cleared BeamO may be its most innovative product yet. Announced on November 13, 2025, BeamO reimagines what a home thermometer can be—turning it into a comprehensive, clinically validated health assessment device that measures temperature, heart activity, and lung sounds in under 60 seconds.
Co-developed with leading hospitals, built on six patent applications, and backed by rigorous FDA review, BeamO enables families and caregivers to capture the kinds of vital signs typically recorded only during medical appointments. For telehealth users, those managing chronic conditions, and anyone seeking more proactive health insights, BeamO sets a new standard for smart health tools.
This guide explains everything potential buyers need to know—how BeamO works, regulatory considerations, use cases, limitations, pricing, and why its FDA clearance is so important.
What Makes BeamO Different?
BeamO is not a typical thermometer. It’s a multi-sensor medical-grade tool engineered to bring professional-level measurements into the home. What makes BeamO groundbreaking is its ability to combine several key health assessments in one device:
- A medically certified 1-lead ECG
- A digital stethoscope for heart and lung sounds
- A contactless infrared thermometer
- AI-enhanced analysis
- Secure telehealth-ready sharing tools
This combination helps families detect symptoms earlier, track respiratory flare-ups, and support physicians with real-world data during virtual visits.
Note: Feature availability varies by region based on local regulatory approval.
BeamO’s FDA Clearance: Why It Matters
FDA clearance confirms BeamO meets strict clinical standards for reliability and safety. It’s not just a wellness gadget—it’s a medically validated device.
This clearance is significant because it:
1. Ensures Clinical-Grade Accuracy
BeamO’s ECG and temperature readings meet rigorous medical benchmarks.
⚠️ Important: BeamO’s ECG can only be used by adults 22+.
In Canada, Withings devices cannot record an ECG due to regulatory constraints.
2. Supports Telehealth & Remote Care
Doctors can access accurate ECG traces, temperature logs, and recorded lung sounds directly from patients.
The ECG analysis is performed via Cardio Check-Up, a Withings+ feature powered by Heartbeat Health’s board-certified physicians.
3. Improves Remote Diagnosis Confidence
BeamO elevates telemedicine from webcam-only conversations to data-driven medical consultations.
How BeamO’s Sensor Technology Works
Withings engineered BeamO using highly miniaturized sensors capable of capturing electrical, infrared, and acoustic data. Each tool plays a critical role.
1. Medically Certified 1-Lead ECG (Electrocardiogram)
Two stainless steel electrodes built into the sides of BeamO allow it to record a heart rhythm strip when held in both hands.
- Results appear instantly on the LED display.
- ECGs sync to the Withings app automatically.
- Users can share results with physicians via HealthLink.
- With Withings+, cardiologists provide a professional review within 24 hours.
Restrictions:
- ECG use is limited to adults 22+.
- Not available on Canadian units.
2. Digital Stethoscope for Heart & Lung Sounds
BeamO’s digital stethoscope uses an advanced piezoelectric acoustic sensor to record chest and back sounds.
Users receive on-screen guidance for proper placement, and doctors can listen live during a telehealth session.
Important clinical note:
The stethoscope feature is not intended to diagnose or monitor medical conditions and cannot detect asthma or bronchitis.³
Its purpose is to record and share lung or heart sounds with a clinician.
Users can also listen to recordings locally via headphones with the included USB-C-to-3.5 mm jack adapter.
3. Advanced Contactless Thermometer
BeamO uses infrared technology to analyze the temporal artery, providing quick and stable temperature readings.
- No contact is needed.
- More precise than traditional forehead scanners.
- Safe for infants, children, and adults.
The improved IR sensor design helps minimize errors caused by slight distance variations from the forehead.
BeamO Use Cases: Who Is It Designed For?
BeamO excels in real-world scenarios where fast, high-quality health data is valuable:
Parents and Families
Children often experience fevers, coughs, and breathing issues. BeamO helps track symptoms over time and share recordings with pediatricians.
Asthma, COPD & Respiratory Patients
Respiratory problems affect millions:
- 22.5M U.S. adults have asthma.
- 4.8M U.S. children have asthma.
- 13M adults experience acute bronchitis annually.
- 9.9M adults live with COPD.
BeamO cannot diagnose lung disease, but consistent symptom reporting gives physicians crucial real-world insight.
Telehealth Users
BeamO transforms virtual visits into data-driven consultations.
Elderly Care & Chronic Condition Monitoring
Daily or weekly measurements help detect early changes in health trends.
HealthLink & the Withings App: Data, Trends & Secure Sharing
BeamO syncs over Wi-Fi or Bluetooth to the Withings app, which becomes the central hub for storing and interpreting health data.
HealthLink for Doctors
HealthLink generates secure, clinician-ready dashboards, including:
- ECG strips
- Temperature logs
- Lung and heart recordings
- Symptom notes
Physicians can access these via a simple web link—no account required.
Withings+ Benefits
BeamO includes one free month of Withings+. Users receive:
- A one-time Cardio Check-Up analyzed by cardiologists
- Personalized health programs
- Behavioral coaching
- Alerts if early signs of deterioration are detected
Price, Availability & Launch Plan
- Price: $249.95
- Where to Buy:Exclusive launch on Withings.com starting Nov. 13, 2025
- Retail Rollout: Amazon and select U.S. retailers in early 2026
- Awards: 24 industry awards, including three CES Innovation Awards (2024)
- Included:
- One free month of Withings+
- One Cardio Check-Up token (ECG review)
Final Verdict: A Major Leap for Home Health
For anyone seeking a smarter, more complete picture of personal or family health, BeamO is the future of connected care.
