WASHINGTON – The March 2014 proposed rule for medical device classification procedures may have struck some in industry as nothing short of a spectacular overhaul of existing rules, but a senior manager at the agency claimed that was not the intent. Jeff Shuren, director of the Center for Devices and Radiological Health, told attendees at a meeting in Washington that in the draft rule, "we really were not trying to make major changes; it was more [about] clarification."

Medtronic (Dublin) seems determined to climb back up on the renal denervation horse. The company has kicked off a new clinical feasibility study that will combine pulmonary vein isolation (PVI) and renal denervation for the treatment of paroxysmal or persistent atrial fibrillation (AF), compared to PVI alone.