Israeli device company Itamar Medical has reported the U.S. FDA clearance of its new and upgraded WatchPAT™ Unified sleep apnea diagnostic device.
Background
Itamar Medical is a public medical technology company developing non-invasive medical devices using its proprietary PAT® signal (Peripheral Arterial Tone). Its two product lines: WatchPAT™, a medical-grade home device for diagnosis of sleep breathing disorders, and EndoPAT™, a non-invasive endothelial function assessment device used to improve risk-stratification and to personalize treatment in symptomatic and cardiovascular disease patients across all disease states.
The FDA clearance of the new device, called “WatchPAT Unified” came earlier than anticipated, and was announced at the recently held Annual Meeting of the Associated Professional Sleep Societies, which took place in Minneapolis, MN.
The “Unified” bit comes from the way the patented PAT® sensor will measure blood oxygen saturation in addition to the PAT® signal in a single Unified probe. In previous models of the WatchPAT™, 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. The newest model, which features a single unified finger probe, simplifies the test procedure, and improves reliability and user comfort while taking the test.
Company comments
Mr. Gilad Glick, CEO of Itamar Medical , said: ““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. Itamar Medical continues to invest great efforts into its R&D with 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.”
Source: Itamar Medical, MarketWatch
published: July 1, 2014 in: Approval/Clearance, Monitoring