Neovasc Plans Next Steps After Thumbs Down From FDA Panel
FDA advisory committee members said the trial population was too small and homogenous and did not establish that Neovasc’s Reducer effectively treats angina.
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The US FDA's Circulatory System Devices Panel will meet on 27 October to evaluate Neovasc’s Reducer device, a minimally invasive treatment for drug-refractory angina.
The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.
Already cleared to monitor the viral load in HIV-positive individuals, the test has now been approved for initial diagnosis as well.