EnsoData has received FDA 510(k) clearance for technology that enables AI-powered sleep diagnosis using FDA-cleared pulse oximetry devices, the company announced this week.

“Expanding EnsoData’s capability to collect and analyze PPG signals from simple, wearable pulse ox devices will accelerate the identification, diagnosis and treatment of sleep-disordered breathing events, including sleep apnea,” EnsoData CEO and President Justin Mortara said in a statement. “With this latest FDA clearance, we expect to build upon and diversify our partner ecosystem to reach more patients with our leading AI solutions.”

According to a release, this new clearance will provide more opportunities for clinicians to effectively reach an undiagnosed patient population by enabling AI-driven analysis using the photoplethysmogram (PPG) signals recorded by pulse oximeters.

510(k) or premarket notification allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. 

To date, EnsoData has supported more than 1,300,000 patients across providers and health systems such as Rush University, Sanford Health and UCHealth.