Home sleep apnea test receives FDA clearance.
Itamar Medical, a company that develops, manufactures and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, has received 510(k) clearance from the U.S. Food and Drug Administration for WatchPAT One, a fully disposable Home Sleep Apnea Test (HSAT).
Gilad Glick, president and chief executive officer of Itamar Medical, said: “WatchPAT One is ideally suited for clinics and practices that recognise the value of HSAT but have limited resources, infrastructure or capital to invest in acquiring or managing our reusable WatchPAT products. 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. We expect the availability of a disposable WatchPAT system will improve patient access by increasing the number physicians able to offer our cutting-edge technology to their patients. Additionally, as a disposable HSAT, WatchPAT One may have particular utility in the inpatient setting, where transmission of infection through reusable medical devices is a significant concern.”
With WatchPAT One, patients pair the WatchPAT device to their smartphone using Itamar’s proprietary app. Sleep study data is collected during the test and automatically sent to CloudPAT, Itamar’s secure server. Once the test is complete, a comprehensive report using WatchPAT’s True Sleep Time, Sleep Architecture and Central Plus algorithms is automatically generated and sent to the prescribing physician. The patient then disposes the WatchPAT device. WatchPAT One utilises the same reimbursement codes as Itamar Medical’s other outpatient WatchPAT studies.
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