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[cite: 311, 327, 518]. 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[cite: 326, 346, 529]. 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[cite: 334, 551, 554, 556]. 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)[cite: 369, 407, 409]. The software provides detailed graphical and numerical reports on sleep latency, duration, quality, and pathology, accessible through any major web browser[cite: 336, 521, 530, 549].
Ranked #8 of 25 clinically evaluated home sleep tests devices
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