EnsoData’s EnsoSleep Gets 510(k) Clearance for New Uses

EnsoData has received 510(k) clearance from the FDA for significant enhancements to its EnsoSleep artificial intelligence-based sleep scoring system.

The software automates the detection of events in sleep studies in medical facilities and in home-based sleep apnea tests. Now cleared for pediatric use, the updated system also includes new event types for chronic respiratory and cardiac patients.

The AI-based system delivers results in 10 minutes, saving clinicians time in diagnosis and treatment of patients, the company said.