Healthcare Industry News:  blood analyzer 

Devices Diagnostics FDA

 News Release - October 11, 2006

EPOCAL Receives FDA Approval to Market the EPOCTM Blood Analysis System

OTTAWA, Oct. 11 (HSMN NewsFeed) - Epocal is pleased to announce receipt of 510(k) clearance from the US Food and Drug Administration to market its first product - the EPOCTM Enterprise Point of Care Blood Analysis System - in the United States.

The EPOC system is a blood analyzer that rapidly performs a panel of the most critical acute care tests at the patient bedside. The product features smart-card-like diagnostic test cards and a portable PDA analyzer with wireless connectivity to the hospital information system.

"We will now commence the commercialization phase of the Company's first product," announced Imants Lauks, Epocal Chief Executive Officer. "As is typical for new technology entrants into the market, we will begin with a controlled launch of our product in the United States in the first quarter of 2007, followed by broader commercialization later in the year."

Dr. James H. Nichols, Director of Clinical Chemistry at Baystate Medical Center, a 700-bed hospital in Massachusetts, has performed clinical evaluations of the EPOC system and had the following comments, "This is the first handheld wireless blood gas and electrolyte analyzer to be introduced into the point of care testing market. With technical performance comparable to blood gas analyzers currently on the market, it will certainly be competitive given its advantages of handheld portability and wireless data connectivity."

Kelly Holman, Managing Director of Genesys Capital Partners of Toronto, Canada, added, "This event is another key milestone for the company as it continues to build value. We look forward to continuing our support of the company on its mission to transform the delivery of patient care at the bedside."

Source: Epocal

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