Neurotronics, a Nihon Kohden company, today 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.

Adding insight from an existing signal

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 apnea 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.

A milestone in software-driven sleep diagnostics

The clearance represents several important milestones for Neurotronics and Nihon Kohden:

  • First FDA-cleared AI/ML-based sleep analysis by Neurotronics. SAM advances the company’s development of clinically validated, software-driven technologies and provides a pathway for future innovation in AI/ML medical devices.
  • Additional clinical information from an existing signal. SAM estimates total sleep time from PPG data already being collected, without requiring additional hardware.
  • Software-only medical device. SAM’s software-based approach creates opportunities to extend advanced sleep analysis capabilities across compatible products and platforms that acquire appropriate PPG signals.

“FDA clearance of the Sleep Analysis Module is a defining milestone for Neurotronics. SAM demonstrates how validated software can provide new clinical information from physiological signals already being collected, without requiring additional hardware. This achievement reflects years of collaboration across engineering, clinical validation, quality and regulatory disciplines and establishes a foundation for continued innovation in software-driven medical technology.”
– Jake Johnson, President and CEO, Neurotronics, LLC.

SAM is a prescription-only device intended for use by, or under the supervision of, a clinician to aid in the diagnosis of sleep disorders in patients 18 years of age and older. TST derived from a PPG signal is an estimate of sleep duration. It is not intended for use when EEG, EOG, and EMG signals are available and full sleep staging is possible, nor is it intended to serve as the sole or primary basis for the diagnosis of any sleep disorder.

Neurotronics is completing the integration and verification activities required for commercial release.

About Neurotronics: Neurotronics, a Nihon Kohden company, is a leader in neurodiagnostic solutions, developing sleep and neurology technology that helps clinicians improve patient care. Based in Alachua, Florida, the company’s products include Polysmith® sleep diagnostic software, the NomadAir® home sleep apnea solution, the Sphinx® PMU710 sleep amplifier, Live View Panel® remote neuromonitoring, and Neurotronics’ sensors. Neurotronics also provides customer support for Nihon Kohden sleep customers in the United States. Learn more at www.neurotronics.com.

About Nihon Kohden: Founded in Japan in 1951, Nihon Kohden is a leading manufacturer, developer and distributor of medical technologies, with subsidiaries throughout the Americas, Europe, and Asia and products used in more than 120 countries. The company develops innovative patient monitoring, neurology, ventilation, cardiology and diagnostic solutions that help clinicians improve patient care across hospitals and healthcare systems worldwide. Its Digital Health Platform (DHP) extends those capabilities by connecting patient monitoring data across devices, systems, and care settings to support connected workflows, advanced analytics, and digital health applications—including solutions such as RemoteSense and AlarmSense—that help healthcare organizations make better use of patient monitoring data. Learn more at us.nihonkohden.com and follow Nihon Kohden on Facebook and LinkedIn.

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