Accumetrics, a healthcare products manufacturer based in San Diego, California, announced that the European Union granted CE Mark approval for its Verify II point-of-care system. The Verify II is designed to measure platelet reactivity in the presence of antiplatelet agents.
According to a press release by the company, regulatory approval in the E.U. is a significant win for the company. The regulatory approval signals the clinical value and importance of platelet reactivity testing. The company plans to pursue expanded commercialization of its VerifyNow II system for use in patients undergoing cardiovascular operations.
Timothy Still is the CEO of Accumetrics. In prepared remarks, he said, "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 VerifyNow I system is currently in use at over 800 healthcare facilities in the United States. In addition, the VerifyNow I has been commercialized in over 70 countries. The device has the ability to reduce the risk of thrombotic health events like stroke and heart attack.
The VerifyNow II system will be launched in the European market in 2013.