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FDA Clears Itamar’s WatchPAT Unified

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Itamar Medical’s upgraded model of the WatchPAT, a sleep apnea diagnostic device, has been cleared by the FDA. This clearance was announced at the SLEEP show.

Within the upgraded WatchPAT Unified, a patented PAT (peripheral arterial tone) 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.

Gilad Glick, CEO of Itamar Medical, says in a release: “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.”

Itamar Medical is a public medical technology company developing noninvasive medical devices using its proprietary PAT signal. Its two product lines are WatchPAT, a medical-grade home device for diagnosis of sleep breathing disorders, and EndoPAT, a noninvasive endothelial function assessment device used to improve risk-stratification and to personalize treatment in symptomatic and cardiovascular disease patients across all disease states.

The PAT signal is measured noninvasively through the fingertips using a custom programmed finger sensor and signal processing algorithms developed by the company.