10:25am Tuesday 31 March 2020

FDA clears disposable home sleep apnea test

An Israeli-based company has received clearance from the U.S. Food and Drug Administration for a new home sleep apnea test, according to a June 6, 2019, announcement from Itamar Medical. The company reports that its WatchPAT One is the first fully disposable home sleep apnea test. Itamar states that the disposable system will increase efficiencies by reducing the time needed to ship, clean and prepare traditional home tests for the next user.

Based on the technology of Itamar’s WatchPAT 300, the WatchPAT One pairs with a patient’s smartphone to collect and send sleep data to a secure server. The information is analyzed through a series of algorithms and reported to the prescribing physician. Once the testing is complete, the patient can throw away the device.

AASM Recommendations for HSATs

According to the AASM’s clinical practice guideline, polysomnography is the standard diagnostic test for the diagnosis of sleep apnea in adult patients in whom there is a concern for obstructive sleep apnea based on a comprehensive sleep evaluation. However, a home sleep apnea test with a technically adequate device can be used for the diagnosis of sleep apnea in uncomplicated adult patients presenting with signs and symptoms that indicate an increased risk of moderate to severe sleep apnea. Additionally, the AASM position statement on home sleep apnea tests acknowledges their value in expanding access to care; however, it notes that it is important for a board-certified sleep medicine physician to be involved in reviewing and interpreting the raw data from the device.

 

 American Academy of Sleep Medicine

 


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