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WideMed Ltd. (WDMD) Receives FDA 510(k) Clearance to Market its Morpheus Ox for Home Sleep Diagnosis


9/12/2011 8:00:34 AM

HERZLIYA, Israel--(BUSINESS WIRE)-- WideMed (TASE:WDMD.ta - News), a leading company engaged in the research, development and sale of innovative products for the growing bio-medical signal diagnostics and treatment market, announced today that the U.S. Food and Drug Administration has granted its home sleep monitoring device, Morpheus Ox, clearance to market in the United States for cardiac patient population.

Morpheus® Ox is WideMed’s portable home sleep diagnostic and monitoring solution. Easy to use, watch-size device enables to perform a sleep test in the comfort of the patient own bedroom.

The Morpheus Ox measures photoplethysmography (PPG) and blood saturation, signals from a standard oximeter device. By utilizing WideMed’s automatic sleep scoring software, Morpheus Ox produces an accurate and reliable sleep study diagnosis, including Sleep/Wake, Apnea Hypopnea Index (AHI) and Cheyne-Stokes Breathing. WideMed developed a unique cellular application capable to record and transmit the data collected during the test.

Morpheus Ox is an innovative device capable of producing automatic sleep diagnostics scoring from the PPG signal and displaying the results to the physicians. The unique proprietary analysis derives a respiratory analyzed signal which is comparable to the measured respiratory signals acquired from full Polysomnography (PSG) sleep study.

The Morpheus Ox Web-based server software is a comprehensive platform which manages a cost-effective sleep services operation, including patient's electronic medical record, cardiac and sleep diagnostics outcomes and a complete workflow management.

Anya Eldan, WideMed's Chief Executive Officer, commented "receiving FDA clearance is a significant achievement for the company. WideMed's innovative technology uses the PPG signal acquired from a standard pulse oximeter to enable an innovative diagnostics of important respiratory and cardiac clinical parameters.

Morpheus Ox is based on the Morpheus platform, a Web-based management solution for large amount of sleep studies from multiple locations over a Secure Cloud. Morpheus OX includes a cost effective standard hardware using commercially across the world.

Please visit www.widemed.com

Contact:

Israeli Investor RelationsFinancial CommunicationMichal EfratyT: 972-523044404michal@fincom.co.il



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