The U.S. Food and Drug Administration has given its first nod to a molecular test developed by Abbott Laboratories for the Zika virus for use to test whole blood. This expands upon an existing use of the test from the Abbott Park, Ill., company; it had already received emergency use authorization for use to test serum, plasma and urine. The whole blood test is expected to enable diagnoses over a longer period of time, up to two months after symptom onset, rather than about a week. That's important since the symptoms of Zika virus are...
The U.S. Food and Drug Administration has given its first nod to a molecular test developed by Abbott Laboratories for the Zika virus for use to test whole blood. This expands upon an existing use of the test from the Abbott Park, Ill., company; it had already received emergency use authorization for use to test serum, plasma and urine.
Vascular Dynamics Inc. has been added to the FDA's Expedited Access Pathway (EAP)program for its Mobiushd device to treat resistant hypertension. The implant is designed to amplify the signals received by baroreceptors located in the carotid artery; these are relayed to the brain in order to lower blood pressure via vasodilation.
The Mountain View, Calif.-based start-up originated in the Israeli med-tech incubator Rainbow Medical and is helmed by a team that's largely from minimally invasive stroke device company Micrus Endovascular, which was acquired by New Brunswick, N.J.-based Johnson & Johnson in 2010 for about $480 million. (See Medical Device Daily, July 13, 2010.)