FDA Expands AI Software EnsoSleep for Pediatric Use, Wider Capabilities

The FDA issued a 510(k) clearance for the artificial intelligence software platform EnsoSleep, expanding its capabilities in assessing patients with chronic respiratory and cardiac conditions, as well as in pediatric populations ages 13 and above.

The FDA Wednesday issued a 510(k) clearance to EnsoData for its artificial intelligence (AI)-assisted sleep scoring software EnsoSleep, allowing for new capabilities and enhancements, and expanding its use in pediatric populations.

As a growing and frequently undiagnosed condition, untreated sleep apnea has been associated with a myriad of comorbidities, including diabetes and depression, as well as increased health care utilization and costs that in total amounts to nearly $150 billion per year.


In addition to increasing risk of respiratory conditions such as influenza and COVID-19, children with untreated sleep apnea have been found in prior research to be 3 times more likely to develop high blood pressure when entering adolescence, which is a strong contributor to cardiovascular disease.

“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 chief executive officer of EnsoData, in a statement.

Designed to automate event detection in polysomnography (PSG) and home sleep apnea tests (HSAT), EnsoSleep analyzes the waveforms found in sleep studies to detect sleep apnea and other sleep disorders. Through the new capabilities, EnsoSleep will now provide an interoperable PSG/HSAT data viewing, editing, and reporting tool that is fully integrated into a web browser, which will allow for data tracking to be conducted beyond the bedside.

Furthermore, novel single channel photoplethysmogram-based total sleep time and sleep-wake staging capabilities will allow for continuous recording of respiratory vitals in HSATs and consumer wearable devices to provide more reliable sleep data to sleep centers and telehealth providers.

“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,” added Fernandez.

Cleared for use in pediatric populations aged 13 and above, EnsoSleep will additionally offer new sleep apnea subtyping and detection capabilities for patients with chronic respiratory and cardiac conditions, including Cheyne-Stokes respiration, periodic breathing episodes, and respiratory rate.

“We want to make a positive impact on the world of health care, 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, in a statement. “We’re excited about the opportunities our newly-FDA cleared capabilities and enhancements have to support sleep professionals in improving patients’ lives.”