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Novametrix Files for
FDA Approval
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Business New Haven
2/4/2000
By: BNH
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WALLINGFORD - Novametrix Medical Systems Inc. has filed a 510(k) application with the U.S. Food & Drug Administration (FDA) for its new Non-Invasive Cardiac Output technology (NICO). Subject to clearance by the FDA, the company plans to launch the product in the second half of its current fiscal year and tap into the $200 million annual market for instruments that measure cardiac output - the majority of which are now invasive. The FDA filing comes one month after the company announced record revenues of $31.6 million for the fiscal year ending May 3 (up 12 percent over the previous year) and net income of $2.9 million.
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