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Medical Devices / Submissions and Approvals

FDA Clears Itamar’s Throw-Away Sleep Apnea Test

June 7, 2019
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Itamar Medical’s WatchPAT One, a disposable home sleep apnea diagnostic, has received 510(k) clearance from the FDA.

The Israeli company’s disposable testing device links with a patient’s smartphone through an app. Sleep study data is collected and automatically transferred to a secure server, where a report is generated and sent to the prescribing physician.

After the test concludes and the report is delivered to the physician, the patient may throw away the device, avoiding the risk of transmitted infections present in reusable medical devices.

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