FDA clears hand-held diagnostic device for OSA
March 3, 2003
CONSHOHOCKEN, Pa. - Viasys Healthcare's Respiratory Technologies Group received FDA 510(k) last month to market Sleepscreen, a hand-held system for the diagnosis of obstructive sleep apnea.
The Sleepscreen will be marketed worldwide by Viasys for the diagnosis of obstructive sleep apnea (OSA). According to published statistics OSA affects approximately 12 million individuals in the United States alone, with the majority undiagnosed. Sleepscreen will be important to clinicians who prefer to test patients without the expense of complex laboratory instrumentation.
Brian Long, product manger for sleep diagnostics stated: "Sleep screen is complementary to our Somnostar diagnostic systems and our sleep therapy products; spiritus Nasal Interface, Orion & Pegasus CPAP.
Sleepscreen's home-orientation and small size allows overnight testing in almost any setting where a patient sleeps. Our market approval includes using the Sleepscreen in the home where it can aid in the detection of OSA and monitor the use of various sleep therapies."
Viasys Healthcare is a global, research-based medical technology company focused in respiratory technology, neuro-care and medical/surgical products.