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FDA approves sleep apnea tech from EnsoData, Samsung

Feb 20, 2024 - healthcareitnews.com
The article discusses the growing prevalence of sleep apnea and the various technological innovations being developed to diagnose and treat it. These include EnsoData's FDA-approved AI algorithm, EnsoSleep, which uses data from any FDA-cleared pulse oximeter to diagnose sleep disorders, and Samsung's FDA-approved sleep apnea feature for the Galaxy Watch, which tracks blood oxygen levels during sleep. Other innovations include a new AI model being developed by Mount Sinai with a $4.1 million grant from the National Heart, Lung and Blood Institute, which will analyze multiple sleep metrics and generate a risk profile for sleep apnea patients.

The article also mentions the challenges in diagnosing sleep apnea and the potential for these technologies to lower healthcare costs and improve patient outcomes. It also highlights the recent recall of Philips Respironics devices, which were found to be connected to 561 deaths, and the company's subsequent order to pay a minimum of $479 million in compensation to users.

Key takeaways:

  • EnsoData has received FDA 510(k) clearance for an AI algorithm called EnsoSleep that aids in the diagnosis of sleep disorders using any FDA-cleared pulse oximeter.
  • Samsung has received FDA approval for a sleep apnea feature on its Galaxy Watch, which tracks blood oxygen levels during sleep.
  • Mount Sinai is developing machine learning to predict the consequences of serious sleep disorders for individual patients, with a recent model predicting sleepiness due to apnea with an accuracy of 87%.
  • The FDA reported that 561 deaths were connected to a 2021 recall of Philips Respironics devices used to treat sleep apnea, leading to the company being ordered to pay a minimum of $479 million in compensation.
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