The US Food and Drug Administration (FDA) granted EnsoData FDA 510(k) clearance for technology that enables artificial intelligence (AI)-powered sleep diagnosis using FDA-cleared pulse oximetry devices. 

Initially cleared by the FDA in 2017 and expanded in 2021, EnsoData’s sleep scoring and study management solution, EnsoSleep, uses AI to analyze the waveforms recorded by in-lab polysomnography and home sleep apnea testing. With the new clearance of EnsoSleep PPG, EnsoData adds the ability to AI score data provided by FDA-cleared pulse oximeters. 

“Expanding EnsoData’s capability to collect and analyze PPG (photoplethysmogram) signals from simple, wearable pulse ox devices will accelerate the identification, diagnosis, and treatment of sleep-disordered breathing events, including sleep apnea,” says Justin Mortara, president and CEO of EnsoData, in a release. “With this latest FDA clearance, we expect to build upon and diversify our partner ecosystem to reach more patients with our leading AI solutions.”

Compared to earlier generations of sleep diagnostic equipment, pulse oximeter devices are smaller and less expensive. They can be as simple to wear as a ring or watch and record physiological data related to sleep and breathing, such as a patient’s oxygen saturation levels and heart rate.

Using this data, EnsoSleep PPG’s deep learning models automatically detect respiratory events, including sleep-disordered breathing events such as apneas or hypopneas, sleep stages including REM, deep sleep, light sleep, wake, and other sleep measures, which may be displayed and edited by a qualified healthcare professional and then exported into a final sleep report for a patient.

By lowering the barrier for patients to receive an accurate sleep test to more widely available pulse oximetry devices, clinicians can expedite the diagnostic process and provide patients with answers to their health problems more quickly, according to a release from EnsoData.