First U.S. Implant of Full-Body MRI-Compatible ICD in IDE Study

Medtronic recently gained the FDA’s nod to commence its IDE study into Evera, and the device has now seen its first implant performed, as part of the Medtronic randomized, global pivotal clinical trial that will enroll up to 275 patients at approximately 45 centers.

Catch-up: Medtronic Wins CoreValve Stay and Covidien’s Pipeline Recall Gets FDA Class

Two of last week’s news items have moved on a bit over the Easter weekend: Medtronic’s increasingly acrimonious spat with Edwards over the respective companies’ transcatheter heart valve offerings, and Covidien’s recall being graded Class I by the FDA.

New Mandible Plate “Seamlessly Integrates Surgical Planning, Intraoperative Tools and Patient Specific Devices

DePuy Synthes CMF has launched its new Patient Specific Plates for Mandible surgery, bringing a new level of accuracy to the procedure and avoiding the risk of bending-induced plate breakage.

FDA Green Light for Boston Scientific’s New Defibrillators and Heart Failure Devices

Boston Scientific Corporation has received FDA approval for its latest generation of defibrillators and heart failure devices, including the DYNAGEN™ MINI and INOGEN™ MINI ICDs, as well as the DYNAGEN™ X4 and INOGEN™ X4 CRT-Ds.

FDA Clears Disposable Feeding Tube Placement Under Direct Vision

Covidien plc has gained U.S. FDA 510(k) Clearance for its Kangaroo™ feeding tube with IRIS Technology. This first-of-its-kind camera-equipped disposable feeding tube is designed to enhance patient safety by providing visualization for a procedure that is currently blinded.

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