Zargis Medical receives FDA approval for marketing Signal X6 device

Sep 18 2009

Zargis Medical Corp., a spin-off from Siemens Corporate Research (NYSE: SI) and a majority-owned subsidiary of Speedus Corp. (Nasdaq: SPDE), announced today it has received U.S. Food and Drug Administration (FDA) clearance to market its new Signal X6(TM) device. Zargis also announced the delivery of seven Signal X6 devices to the U.S. Army for deployment in six Department of Defense medical facilities.

Signal X6 is noninvasive, easy to use and simultaneously records heart and lung sounds from six adhesive sensors. The recordings can be evaluated locally or, for locations where a cardiac specialist is not immediately available for consultation, transmitted through the Internet for remote evaluation. Signal X6 and our recently launched Zargis Cardioscan(TM) device were both designed for user-friendly digital heart sound analysis. The configuration of the Signal X6 provides a unique telemedicine resource in situations where evaluations would benefit from high fidelity multi-channel synchronous recordings.

"As healthcare systems continue to demand improved outcomes with utilization of fewer resources, we believe that Signal X6 will provide cost-effective, high quality cardiac analysis in situations where it's not practical for a patient to visit a specialist," said John Kallassy, Zargis' CEO.

Prototypes for Signal X6 were first developed with funding from the Telemedicine and Advanced Technology Research Center (TATRC) through the AAMTI program. The AAMTI program provides funding to AMEDD personnel to demonstrate technology and document the impact on cost, access and quality of care. TATRC is an element of the United States Army Medical Research and Materiel Command (USAMRMC).