Israel-based Itamar Medical has received clearance from the US Food and Drug Administration (FDA) for the new and upgraded model of its sleep apnea diagnostic device, WatchPAT.
The new model of the WatchPAT device, which is considered to be an advanced home sleep diagnostic device, now allows the test to be performed using a single finger to collect both oximetry and PAT data in a Unified probe.
In earlier 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.
A single unified finger probe feature in the new model simplifies the test procedure, improving reliability and user comfort during the test.
Itamar Medical CEO Gilad Glick said this is a substantial achievement for the company.
"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," Glick said.
"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 develops non-invasive medical devices using its peripheral arterial tone (PAT) signal.
The company’s two product lines include 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 personalise treatment in symptomatic and cardiovascular disease patients across all disease states.
According to the company, the PAT signal is measured non-invasively through the finger tips using a custom programmed finger sensor and signal processing algorithms, and validated in hundreds of scientific publications.
Image: The new WatchPAT Unified model. Photo: courtesy of Business Wire.