Withings ScanWatch 2 (HSAT)
Withings
by Sibel Health • Model: ANNE Sleep (510k: K220095)
ANNE Sleep is a wireless monitoring platform indicated for the collection, analysis, display, and storage of physiological parameters to aid in the evaluation of sleep-related breathing disorders in adults. The system utilizes two skin-mounted, bio-integrated sensors placed on the chest and finger to measure heart rate, oximetry, and respiratory signals.
Eligibility may vary by provider and plan. Check with your HSA/FSA administrator for specific details.
Evidence-based evaluation by medical professionals
"A soft, wireless wearable system that brings laboratory-grade sleep analysis to the home through innovative flexible sensor technology."
The ANNE Sleep system by Sibel Health represents a significant advancement in wearable sleep diagnostics, moving away from rigid hardware to flexible, epidermal electronics. Utilizing a wireless dual-sensor configuration, it records a comprehensive suite of physiological data including ECG, chest wall movement, peripheral arterial tonometry (PAT), SpO2, heart rate, and snoring. In a large multicenter clinical trial involving 225 subjects, the system demonstrated exceptional diagnostic accuracy for moderate and severe obstructive sleep apnea (OSA), showing 90% sensitivity and 98% specificity when compared to gold-standard polysomnography (PSG). A key clinical differentiator is its AI-enabled sleep-wake classifier, which uses deep learning to identify sleep stages and provide True Sleep Time, reducing the risk of disease underestimation common in Type III and IV tests that only measure recording time. The device is cleared by the FDA and is specifically designed to facilitate clinical-grade monitoring in both home and research environments.
Ranked #4 of 25 clinically evaluated home sleep tests devices
Withings
Sunrise SA
Sibel Health
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Sibel Health
Our #1-ranked home sleep tests device demonstrated superior performance across key clinical metrics. Compare detailed specifications to make an evidence-based selection.
Verified retailers and current pricing
Available for clinical procurement; prescription required.