Neurotronics, a Florida-based developer of sleep and neurology diagnostic technologies, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sleep Analysis Module (SAM), an artificial intelligence-powered software solution designed to estimate total sleep time using physiological data collected during home sleep apnea testing.
The prescription-only software uses artificial intelligence and machine learning algorithms to analyze photoplethysmography (PPG) signals obtained from pulse oximeters. By estimating sleep duration, SAM provides clinicians with additional information to support the assessment of sleep apnea severity, potentially improving the interpretation of home-based diagnostic studies.
Neurotronics plans to integrate SAM into its existing Polysmith sleep diagnostic software platform, enabling the analysis of studies conducted using the company's NomadAir home sleep apnea testing system. The technology is intended for use in adults aged 18 years and older.
A key feature of SAM is its ability to extract additional clinical information from physiological signals already collected during sleep testing, eliminating the need for supplementary monitoring hardware.
"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," said Jake Johnson, president and CEO of Neurotronics.
The regulatory clearance reflects ongoing developments in AI-enabled sleep diagnostics, particularly technologies designed to enhance home sleep apnea testing through software-based analysis of existing physiological measurements.
Other companies are pursuing similar approaches. EnsoData received FDA clearance in 2024 for technology that analyzes PPG signals from FDA-cleared pulse oximeters to support sleep disorder diagnosis.
In 2025, EnsoData expanded its EnsoHST offering to incorporate acoustic airflow, snoring, and movement information using smartphone microphones and accelerometers in compatible devices, without requiring additional hardware.
These developments reflect growing industry interest in using AI and existing sensor technologies to expand the diagnostic information available from home-based sleep assessments.
For Neurotronics, integrating SAM into Polysmith represents an extension of its existing diagnostic software capabilities, supporting clinicians in evaluating sleep apnea through additional physiological data analysis.
The clearance establishes a regulatory foundation for Neurotronics to incorporate AI-derived sleep duration estimates into its home sleep testing workflow.
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