Clinical Trials
23
8 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2008
Active, not recruiting
6
26.1%
Completed
13
56.5%
Enrolling By Invitation
1
4.3%
Not yet recruiting
1
4.3%
Recruiting
1
4.3%
Withdrawn
1
4.3%
No approval data available
- Withings has received FDA clearance for BeamO, a revolutionary health monitoring device that combines electrocardiogram, digital stethoscope, and thermometer functions in a single portable unit. - The device enables at-home measurement of vital signs typically assessed during medical consultations, performing complete health check-ups in under one minute for enhanced telehealth capabilities. - BeamO is now available in the US for $249.95 exclusively through Withings.com, with plans for Amazon and retail partner availability in early 2026. - The device integrates with the Withings app's HealthLink feature for secure data sharing with healthcare providers and offers optional Cardio Check-Up services through board-certified cardiologists.
- Withings has launched its BPM Vision blood pressure monitor in the US after receiving FDA clearance, priced at $149.95, slightly higher than initially anticipated at CES 2025. - The device features a 2.8-inch color screen that guides users through proper measurement techniques, provides reading interpretations, and includes interchangeable cuffs to accommodate various adult arm sizes. - BPM Vision transfers readings to the Withings app via Wi-Fi, allowing users to generate reports for healthcare providers, with additional telemedicine services available through the $100/year Withings+ subscription.
- The FDA has approved sleep apnea detection for Apple Watch Series 9, Series 10, and Watch Ultra 2, accessible via the upcoming watchOS 11 update. - The feature requires 10 nights of sleep tracking over 30 days, utilizing the accelerometer to identify potential sleep disturbances. - Apple emphasizes that the feature is not a diagnostic tool but an over-the-counter risk assessment, prompting users to seek professional diagnosis. - This approval follows similar clearances for sleep apnea detection in devices from Withings and Samsung's Galaxy Watch line.
- The FDA has granted 510(k) clearance to Withings' Sleep Rx Mat, a device designed to aid in the diagnosis of sleep apnea in adults. - The under-mattress mat tracks sleep, breathing, and cardiovascular activity, providing users with a sleep quality score and detailed sleep data. - The device uses pneumatic, sound, and motion sensors to monitor respiratory rate, heart rate, sleep cycles, snoring, and breathing disturbances. - Withings' VP, Antoine Robillard, highlights the potential for Sleep Rx to improve OSA diagnosis and reduce the economic burden of undiagnosed sleep apnea.
- Withings Sleep Rx has received FDA clearance, marking a significant advancement in sleep apnea diagnosis by offering a convenient alternative to traditional in-lab testing. - The device is non-intrusive, fitting under any mattress, and provides detailed analysis of sleep, breathing, and cardiovascular activity for accurate sleep apnea diagnosis. - Sleep Rx aims to improve access to diagnosis and patient outcomes through early detection and treatment, potentially reducing the $150 billion annual economic burden of undiagnosed sleep apnea.
