New EnsoSleep FDA Clearance Includes Total Sleep Time for HSATs, Pediatric Scoring & Web-Based Platform

EnsoData Receives 510(k) Clearance of Latest Sleep Center Tools to Enhance Patient Care and Experience; Expands into Pediatrics and Unlocks Next Generation Home Testing Capabilities

EnsoData, today announces its FDA 510(k) clearance of new capabilities and enhancements to its product EnsoSleep, a leading AI-assisted sleep scoring solution. With a substantial clinical study size, EnsoSleep’s validation metrics support diagnostic accuracy, helping sleep labs and healthcare systems provide care more efficiently and improve patient outcomes across the globe.

Originally cleared by the FDA in 2017, this additional clearance expands EnsoSleep’s capabilities to enhance the care sleep providers can provide in today’s ever-evolving healthcare environment:

● EnsoTST: EnsoSleep’s variation of total sleep time, which is powered by single
channel photoplethysmogram (PPG) data, as PPG is among the most ubiquitous,
continuously recorded vitals in HSAT devices. The new capabilities with TST will
make HSAT diagnosis more reliable as well as increasing access to important sleep
data for consumers

● Sleep scoring and staging for pediatrics (ages 13 and up): This is AI cleared for
pediatric populations above 13. It will help clinicians diagnose sleep apnea in
adolescent and teen patients, which if left untreated, has been associated with poor cognitive and school performance, as well as psychiatric and behavioral problems

● EnsoViewer: EnsoSleep now provides an interoperable PSG/HSAT data viewing,
editing, and reporting tool, optimized for clinician experience, and fully inside the web browser, so device data is no longer tethered to the bedside

● New event types for chronic respiratory and cardiac patients: The new update
introduces additional sleep apnea subtyping and detection capabilities, including
Cheyne-Stokes respiration, periodic breathing episodes, respiratory rate, and more

“The enhancements made to EnsoSleep expand patient access to quality care at home and improve the depth and breadth of sleep data available today. We continue to emphasize interoperability in sleep care, as we roll out an interoperable viewer and provide clinical support for most devices on the market,” said Chris Fernandez, co-founder and CEO of EnsoData. “EnsoData is uniquely positioned to reduce the financial and personal stress that sleep clinicians face when delivering patient care.”

To learn more about EnsoSleep, click here.

Source: EnsoData

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