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FDA Clears Artificial Intelligence to Transform Sleep Care

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The updates will help sleep clinicians provide care more efficiently in today’s fast-paced and fast-changing healthcare environment, save labs and healthcare systems money, support diagnostic accuracy, and ultimately improve patient outcomes across the globe


MADISON, Wis. (PRWEB)

EnsoData, the company simplifying the process for analyzing the human body to help clinicians more precisely diagnose health conditions, today announces its FDA 510(k) clearance of new capabilities and enhancements to its product EnsoSleep, an AI-assisted sleep scoring solution that automates event detection in Polysomnography (PSG) and Home Sleep Apnea Tests (HSAT). The updates will help sleep clinicians provide care more efficiently in today’s fast-paced and fast-changing healthcare environment, save labs and healthcare systems money, support diagnostic accuracy, and ultimately improve patient outcomes across the globe.

“Sleep apnea is a major comorbidity to some of the most detrimental physical and mental health complications a person can face in their lifetime,” said Chris Fernandez, co-founder and CEO of EnsoData. “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, while also laying the foundation for the future, with our growing provider and technology partner ecosystem, to provide more accurate wearable health tracking to consumers down the line.”

The FDA 510(k) clearance includes major updates to EnsoSleep, including:

  • Single channel photoplethysmogram (PPG) based Total Sleep Time (TST) and Sleep-Wake Staging: PPG is among the most ubiquitous, continuously recorded respiratory vitals in HSATs and consumer wearables/smartwatches, and its use to measure sleep will make HSAT diagnosis more reliable as well as increasing access to important sleep data for consumers

  • Sleep/Neuro AI device for pediatrics (ages 13 and up): As a new sleep-related AI cleared for pediatrics, 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

  • Interoperable Viewing Software: EnsoSleep now provides an interoperable PSG/HSAT data viewing, editing, and reporting tool, optimized for user 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

Why it Matters:

Sleep apnea is associated with a variety of comorbidities, including increased risk for high blood pressure, heart problems, diabetes, depression, liver problems, complications with medications, surgeries, pregnancies, and issues with bed partners. Sleep apnea affects millions of Americans and costs the U.S. nearly $150B per year — yet up to 80 percent of patients go undiagnosed and untreated. By analyzing the waveforms found in sleep studies, EnsoData is able to detect sleep apnea and other sleep disorders — providing critical infrastructure that supports sleep centers and telehealth providers across the country in positively impacting the health of their patients, the wellbeing of their clinician staff, and the achievement of their patient access, outcomes, and experience goals.

“We want to make a positive impact on the world of healthcare, starting with sleep, and that begins by empowering clinicians with reliable, world-class tools that enable them to spend more time with patients, ” said Sam Rusk, co-founder and President of EnsoData, “We’re excited about the opportunities our newly-FDA cleared capabilities and enhancements have to support sleep professionals in improving patients’ lives.”

To learn more about EnsoSleep, visit ensodata.com/ensosleep/

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About EnsoData

EnsoData simplifies the process for reading and analyzing the human body to quickly and precisely diagnose conditions, starting with sleep. Using artificial intelligence, EnsoData’s technology analyzes billions of data points collected from sensors placed throughout the entire human body to automate event detection, deliver easy-to-read reports, and aid clinicians in increasing patient access to accurate diagnoses. Heartbeats on an EKG, eye movements through an EOG, and brain waves through an EEG all output as waveform data; EnsoData leads the world in reading and understanding waveforms. Learn more at ensodata.com.

Press Contact

Tess Pawlisch, Public Relations Director

ensodata@thekeypr.com

Rachel Boer, Marketing Director

rachel@ensodata.com

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