CINCINNATI – U.S. FDA reorganization took center stage Wednesday at FDA/Xavier MedCon 2019, with Jeff Shuren, director of the Center for Devices and Radiological Health, unveiling the official implementation of the new Office of Product Evaluation and Quality (OPEQ), something the agency also reported the same day. "We've been trying to apply – and have been applying – a total product life cycle approach for our decision making for many years. However, organizationally, we have not been well-structured to support that approach," Shuren told attendees of the conference, which is taking place this week in Cincinnati.

Abbott Laboratories' High-Sensitive Troponin-I blood test was the first to be given a CE mark in Europe last fall for the prediction of heart disease risk when used alongside other assessments. Now, a prospective, epidemiologic U.S. study has shown that the test can be used to identify adults at risk of a cardiac event even independent of other heart disease risk factors.