Medtronic plc has won FDA clearance for its Cardioinsight noninvasive 3-D mapping system. The device, which has been approved in Europe for nearly five years, is used to improve the mapping of electrical disorders of the heart. The Dublin-based company first gained access to the device through its $93 million acquisition of Cleveland-based Cardioinsight Inc. (See Medical Device Daily, June 22, 2015.) Read More
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.)
