Accumetrics touts CE Mark for next-gen VerifyNow II System

January 3, 2013 by MassDevice staff

Accumetrics' next-gen VerifyNow II System lands CE Mark approval for sale in European markets, anticipating commercial launch early this year.

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Accumetrics won CE Mark approval in the European Union for its next-generation VerifyNow II System, a device designed for point-of-care measurement of platelet reactivity to antiplatelet agents.

The regulatory is a big win for Accumentrics and validation of the clinical value of platelet reactivity testing, according to the company, which expects to expand market opportunities for the VerifyNow System in surgical and interventional cardiology patients, according to the press release.

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"As the clinical role of platelet reactivity testing continues to gain traction in the interventional cardiology marketplace, we are pleased to see additional clinical specialties, such as surgery and Interventional Neuroradiology, demonstrate an increased need for platelet reactivity testing as well," president & CEO Timothy Still said in prepared remarks. "As the leader in platelet reactivity testing, we remain focused on producing high quality diagnostic tests that provide critical information to physicians to help improve the quality of care for patients on these life-saving antiplatelet agents."

The current VerifyNow System is used in over 800 facilities in the U.S. and over 70 countries worldwide to reduce the occurrence of thrombotic events such as heart attack and stroke, the company said.

Accumetrics said the company will launch the VerifyNow II System in the European market early this year.

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