Neurotronics, a Nihon Kohden company, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Sleep Analysis Module (SAM).

SAM is a software-only medical device that includes a total sleep time (TST) algorithm. The algorithm analyzes a photoplethysmography (PPG) signal to estimate TST and aid health care professionals in the evaluation of sleep disorders.

SAM represents the first FDA-cleared AI/ML-based sleep analysis algorithm within Neurotronics and establishes a foundation for continued innovation in software-driven sleep diagnostics.

In sleep apnea assessment, respiratory events are evaluated relative to the amount of time a patient is asleep. Many home sleep studies rely on total recording time because measuring sleep itself has traditionally required additional signals, including electroencephalography (EEG), electrooculography (EOG), and electromyography (EMG).

SAM estimates TST using the PPG signal already being collected by a pulse oximeter, providing additional clinical information without requiring an additional sensor or changing the patient setup.

This distinction can be important when evaluating obstructive sleep devdeapnea severity. The apnea-hypopnea index (AHI) is based on the number of respiratory events relative to sleep time. When total recording time is used instead, periods when the patient is awake may be included in the calculation. SAM provides clinicians with an estimated TST that more closely reflects the patient's sleep duration.

SAM will initially be integrated into Neurotronics' Polysmith sleep diagnostic software for analysis of studies recorded using the NomadAir home sleep apnea testing (HSAT) solution. By using the PPG signal already acquired by NomadAir, SAM enables clinicians to evaluate home sleep studies using estimated sleep time rather than total recording time, without additional sensors or changes to the patient setup.