by SleepImage • Model: SleepImage System Version 2.28
The SleepImage System is a Class II Software as a Medical Device (SaMD) designed to aid healthcare professionals in the evaluation, diagnosis, and management of sleep-disordered breathing. It processes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically recorded during sleep, using proprietary auto-scoring algorithms to generate a SleepImage Apnea Hypopnea Index (sAHI) and other clinical metrics.
Eligibility may vary by provider and plan. Check with your HSA/FSA administrator for specific details.
Evidence-based evaluation by medical professionals
"A high-precision, FDA-cleared analytical platform that transforms wearable cardiac and oximetry data into hospital-grade sleep diagnostic reports."
The SleepImage System is a cloud-based Software as a Medical Device (SaMD) intended to aid healthcare professionals in the evaluation, diagnosis, and management of sleep disorders. Unlike basic lifestyle trackers, this system is FDA-cleared to establish sleep quality and provide a SleepImage Apnea Hypopnea Index (sAHI) for children, adolescents, and adults. The platform operates by automatically analyzing digital signals-typically Electrocardiogram (ECG) or Plethysmogram (PLETH) paired with oxygen saturation (SpO2)-collected during sleep via Bluetooth-compatible data sources like the SleepImage PO6 ring or standardized EDF files. Clinical evaluation of the system is robust, involving the analysis of over 2,000 sleep studies to confirm that its auto-scoring algorithms generate outputs comparable to manual human scoring from polysomnography (PSG). The software provides detailed graphical and numerical reports on sleep latency, duration, quality, and pathology, accessible through any major web browser.
Ranked #9 of 25 clinically evaluated home sleep tests devices
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Our #1-ranked home sleep tests device demonstrated superior performance across key clinical metrics. Compare detailed specifications to make an evidence-based selection.
