EnsoData Platform Updates Receive FDA Approval

by Taylor Kennedy

EnsoData announced today its FDA 510(k) clearance of new capabilities and enhancements to its product, EnsoSleep.

According to a release, the updates will help sleep clinicians provide care more efficiently, save labs and healthcare systems money, support diagnostic accuracy and ultimately improve patient outcomes across the globe.

“Our enhancements to EnsoSleep will help to further expand patient access to quality care at home and improve the depth and breadth of sleep data available today,” EnsoData CEO Chris Fernandez said in a statement. “With our growing provider and technology partnership ecosystem, we hope to provide more accurate wearable health tracking to consumers down the line.”

Specific updates include a sleep/neuro AI device for pediatrics and interoperable viewing software.