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SOMANETICS INTERRUPTS SHIPMENTS OF CEREBRAL OXIMETER

 TROY, Mich., Dec. 2 /PRNewswire/ -- Somanetics Corporation (NASDAQ-NMS: SMTS) announced that the company received notification from the U.S. Food and Drug Administration claiming to rescind the company's 510(k) pre-market notification to market and promote its product. Based upon this notification, the company has interrupted shipments of its INVOS(R) 3100 Cerebral Oximeter. Somanetics disagrees with and is appealing the FDA's action. The company has requested an immediate meeting with the FDA, and is hopeful that upon the FDA's review of its appeal, an expeditious resolution of this matter can be reached.
 The INVOS 3100 Cerebral Oximeter is the first product of its kind to monitor, noninvasively, directly and continuously, the oxygen saturation of the blood in portions of an adult's brain. Without sufficient oxygen, brain cells die within minutes, possibly resulting in paralysis, severe and complex disabilities, irreversible brain damage or death. The Cerebral Oximeter uses harmless, low-intensity near-infrared light to provide such information that assists surgeons, anesthesiologists and other medical personnel in taking corrective action when needed.
 In addition, the prevention of certain types of brain injuries can result in shorter patient hospital stays and decreased costs related to patient care after surgery. INVOS is an acronym for "In Vivo Optical Spectroscopy," Somanetics' proprietary technology.
 Somanetics' Common Shares and Class B Warrants are publicly traded on the NASDAQ National Market under the symbols SMTS and SMTSZ, respectively.
 -0- 12/2/93
 /CONTACT: Mary Ann Robb of Somanetics, 313-689-3996/
 (SMTS)


CO: Somanetics Corporation ST: Michigan IN: MTC SU:

SB -- DE011 -- 9628 12/02/93 08:56 EST
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Publication:PR Newswire
Date:Dec 2, 1993
Words:259
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