FDA clearance for latest WatchPAT device

MEDICAL technology company Itamar Medical (Caesarea, Israel) said that the new and upgraded model of its leading sleep apnea diagnostic device, the WatchPAT? Unified, has been cleared by the US Food and Drug Administration (FDA) to diagnose sleep apnea with sleep stages in a home setting.

The new WatchPAT? Unified model ensures a reliable, accurate, and simple sleep apnea diagnostic experience for the patient in the home setting, says Itamar Medical

The FDA clearance came earlier than anticipated, and was announced at Sleep 2014, the annual meeting of the Associated Professional Sleep Societies, which took place in Minneapolis, MN, with 4,800 sleep physicians and professionals attending the conference.

Within the WatchPAT Unified, the patented PAT? (Peripheral Arterial Tone) sensor will measure blood oxygen saturation in addition to the PAT signal in a single Unified probe.

The newest model, which features a single unified finger probe, simplifies the test procedure, and improves reliability and user comfort while taking the test. In previous models, the patient wore a watch-like device on the wrist with two finger sensors attached to it, one measuring the PAT signal and one oximetry sensor measuring blood oxygen saturation.

“This is a substantial achievement for Itamar Medical. We expect our channels to the market, both through our direct sales force to the core sleep physicians and through our exclusive relationships in the cardiology space to benefit from this FDA cleared innovation,” said CEO Gilad Glick.

Itamar Medical continues to invest into developing non-invasive medical devices using its proprietary PAT? signal, he said. “Our goal to continuously lead the home sleep test market for diagnosing Sleep Apnea and sleep related breathing disorders, while keeping it simple and comfortable for the patient.”