EnsoData announced today that it received FDA 510(k) clearance for technology that enables AI-powered sleep diagnosis using pulse oximetry devices.
Powered by the company’s EnsoSleep PPG scoring, widely available, wearable, FDA-cleared pulse oximetry technology can be used for this purpose. It enables a high-quality, accessible and cost-effective approach to diagnosing sleep disorders, including sleep apnea.
Madison, Wisconsin–based EnsoData designed its previously FDA-cleared EnsoSleep diagnostic AI analysis and sleep scoring solution to use machine learning. It analyzes data from traditional sleep studies to aid physicians in diagnosing sleep disorders.
The latest FDA clearance enables EnsoSleep PPG to give clinicians more opportunities to reach an undiagnosed patient population. EnsoData says the AI-driven analysis uses photoplethysmogram (PPG) signals recorded by widely used pulse oximeters.
“Expanding EnsoData’s capability to collect a…