EnsoData wins FDA nod for AI sleep diagnosis tech using pulse oximeters

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 a…

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Inspire Medical Systems invests in EnsoData and Ognomy

Sleep apnea treatment developer Inspire Medical Systems has invested in two private companies with digital health tech that could better screen people for sleep problems.

Minneapolis-based Inspire Medical is the maker of a minimally-invasive, implantable device that uses neurostimulation to treat obstructive sleep apnea. It made a $10 million minority equity investment in Madison, Wisconsin–based EnsoData, creator of an FDA-approved sleep study analysis platform called EnsoSleep. The EnsoSleep platform integrates with a sleep labs’ existing software and diagnostic devices, using AI to automatically analyze and score sleep studies.

Inspire Medical also provided seed funding to Buffalo, New York–based Ognomy, creator of the Ognamy app that sleep physicians built to shift sleep apnea diagnosis and treatment from the clinic to people’s homes.

Tim Herbert, CEO of Inspire Medical Systems, said the tools created by EnsoData and Ognomy could help clinician…

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