WITHINGS | MedPath

Withings BPM Vision Blood Pressure Monitor Receives FDA Clearance and Launches in US Market

2 months ago

• 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.

Apple Watch Receives FDA Clearance for Sleep Apnea Detection

8 months ago

• 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.

Withings' Sleep Rx Mat Receives FDA 510(k) Clearance for OSA Diagnosis Assistance

8 months ago

• 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 Receives FDA Clearance for Home Sleep Apnea Testing

8 months ago

• 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.