Home » EnsoData’s EnsoSleep Gets 510(k) Clearance for New Uses
EnsoData’s EnsoSleep Gets 510(k) Clearance for New Uses
July 16, 2021
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.
Upcoming Events
-
21Oct