EPOCAL's EPOCâ„¢ Blood Analysis System, Received USFDA 510(k) Approval

Filed in archive Diagnostics on October 15, 2006

EPOCAL recently announced that its first product- the EPOCâ„¢ Enterprise Point of Care Blood Analysis System - has been approved for marketing in the United States by the power of a USFDA 510(k) approval.

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

How's that for high-tech diagnostic?

According to Imants Lauks, Epocal Chief Executive Officer:

"We will now commence the commercialization phase of the Company's first product. 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."

Director of Clinical Chemistry at Baystate Medical Center ( a 700-bed hospital in Massachusetts), Dr. James H. Nichols, has already performed clinical evaluations of the EPOC system , commented: "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."

Read the full press release from PR Newswire.