FDA Expands AI Software EnsoSleep for Pediatric Use, Wider Capabilities

The FDA has issued a 510(k) approval for the artificial intelligence software platform EnsoSleep, expanding its capabilities for assessing patients with chronic respiratory and cardiac disease and in pediatric populations 13 years and older.

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

As a growing and often undiagnosed condition, untreated sleep apnea has been linked to a host of comorbidities, including diabetes and depression, as well as increased health care use and costs totaling nearly $150 billion a year.

In addition to an increased risk of respiratory diseases such as the flu and COVID-19, previous research has found that children with untreated sleep apnea are 3 times more likely to develop high blood pressure entering adolescence, which is a strong contributor to cardiovascular disease. vascular disease.

“Sleep apnea is a major comorbidity of some of the most damaging physical and mental health complications a person can face in their lifetime,” Chris Fernandez, co-founder and CEO of EnsoData, said 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. With the new capabilities, EnsoSleep now offers an interoperable PSG/HSAT data viewing, editing and reporting tool that is fully integrated into a web browser, enabling data tracking to be performed outside of bed.

In addition, new photoplethysmogram-based total sleep time and sleep-wake staging capabilities for continuous recording of respiratory vitals in HSATs and consumer wearable devices will provide more reliable sleep data for sleep centers and telehealth providers.

“Our enhancements to EnsoSleep will help to further expand patients’ 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 ecosystem of suppliers and technology partners, to provide more accurate wearable health tracking for consumers across the board,” Fernandez added.

Additionally, approved for use in pediatric populations 13 years and older, EnsoSleep will provide new sleep apnea subtyping and detection capabilities for patients with chronic respiratory and cardiac disease, including Cheyne-Stokes breathing, intermittent respiratory episodes, and respiratory rate.

“We want to make a positive impact on the world of healthcare, starting with sleep, and that starts by providing clinicians with reliable, world-class tools that allow them to spend more time with patients,” said Sam Rusk, co-founder and president from EnsoData, in a statement. “We are excited about the opportunities our recently FDA-approved capabilities and enhancements have to support sleep professionals in improving patients’ lives.”

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