EnsoData announced today that it received FDA 510(k) clearance for technology that enables AI-powered sleep diagnosis using pulse oximetry devices.
Powered by the company’s EnsoSleep PPG scoring, widely available, wearable, FDA-cleared pulse oximetry technology can be used for this purpose. It enables a high-quality, accessible and cost-effective approach to diagnosing sleep disorders, including sleep apnea.
Madison, Wisconsin–based EnsoData designed its previously FDA-cleared EnsoSleep diagnostic AI analysis and sleep scoring solution to use machine learning. It analyzes data from traditional sleep studies to aid physicians in diagnosing sleep disorders.
The latest FDA clearance enables EnsoSleep PPG to give clinicians more opportunities to reach an undiagnosed patient population. EnsoData says the AI-driven analysis uses photoplethysmogram (PPG) signals recorded by widely used pulse oximeters.
“Expanding EnsoData’s capability to collect and analyze PPG signals from simple, wearable pulse ox devices will accelerate the identification, diagnosis and treatment of sleep-disordered breathing events, including sleep apnea,” said Justin Mortara, President and CEO of EnsoData. “With this latest FDA clearance, we expect to build upon and diversify our partner ecosystem to reach more patients with our leading AI solutions.”
More about this new sleep diagnostics solution from EnsoData
EnsoData says pulse oximetry devices offer smaller size and lower costs compared to earlier generations of sleep diagnostic equipment. Some come in the form of wearable rings and watches as they record physiological data related to sleep and breathing. That data includes oxygen saturation levels and heart rate.
Using the data collected by pulse oximetry, EnsoSleep PPG’s deep learning models automatically detect respiratory events. That includes sleep-disordered breathing events like apneas or hypopneas, plus sleep stages and other sleep measures. These can be displayed and edited by a qualified healthcare professional, then exported into a final sleep report for a patient.
EnsoData says the offering can lower the barrier for patients to receive an accurate sleep test thanks to pulse oximetry’s wider availability.
“Our interoperable AI tools are democratizing the ability to accurately measure sleep and aid in diagnosis of sleep disorders broadly – for the existing category of FDA-cleared pulse oximetry devices and sensors that are already widely deployed, in-use clinically, and growing in their adoption daily. With PPGs among the most commonplace of medical waveforms collected across healthcare settings, from diagnostic tests to bedside monitors and consumer wearables, this will be transformative for patient access and outcomes to achieve better sleep and overall health,” said Chris Fernandez, Co-founder and CRO of EnsoData. “This FDA clearance marks a pivotal moment in sleep diagnostics, and also long-term therapy monitoring and management, where enhanced accessibility and affordability can create a new normal in sleep care.”