Itamar Medical has received approval from the US Food and Drug Administration (FDA) for its new and upgraded model of the WatchPAT sleep apnea diagnostic device, WatchPAT Unified.
WatchPAT Unified is considered an advanced home sleep diagnostic device in the market. The device allows the test to be performed using a single finger to collect both oximetry and PAT data in a Unified probe.
WatchPAT Unified features a PAT sensor that measures blood oxygen saturation in addition to the PAT signal in a single Unified probe.
Featuring the single unified finger probe, the WatchPAT Unified simplifies the test procedure, while improving reliability and user comfort during the test.
The previous models of the WatchPAT had two finger sensors, one measuring the PAT signal and one oximetry sensor measuring blood oxygen saturation.
Itamar Medical CEO Gilad Glick said that the company expects its channels to the market, both through its direct sales force to the core sleep physicians and through the company’s 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," Glick added.
WatchPAT is a medical-grade home device for diagnosis of sleep breathing disorders. The PAT signal is measured non-invasively through the finger tips using a custom programmed finger sensor and signal processing algorithms developed by the company.
Image: Itamar Medical’s new WatchPAT Unified model. Photo: Courtesy of Business Wire