FDA clears Itamar's disposable home sleep apnea test

The company also believes the disposable test will be a good match for practices with limited resources or capacity to invest in reusable products. (Image: Itamar Medical)

Itamar Medical has received an FDA clearance for its fully disposable test for sleep apnea.

Though usable at home, the company said the newer version of its WatchPAT test hardware—which launched earlier this year—is also suited for use in the clinic, where the transmission of infections can be a concern.

“WatchPAT One offers patients and physicians the same simplicity, accuracy and reliability as WatchPAT 300 without the need for return shipping, downloading, cleaning or preparation for the next study,” Itamar President and CEO Gilad Glick said in a statement.


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The company also believes the disposable test will be a good match for practices with limited resources or capacity to invest in reusable products, ultimately increasing patient access, Glick said. WatchPAT One also uses the same reimbursement codes as Itamar’s other outpatient studies.

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Patients can pair the WatchPAT wearable to their smartphone to collect sleep data and upload the results to Itamar’s servers. The company then generates a report measuring sleep time and other factors, which is sent to the prescribing physician.

Placed on the fingers and wrist, the device measures movement, snoring, heart rate and pulse oximetry. It also tracks peripheral arterial tone, a signal pattern caused by changes in the nervous system, that Itamar’s algorithms use to identify respiratory disturbances during sleep.

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