Medtronic CEO Geoff Martha [Image courtesy of Medronic]
In October, the medtech giant announced that the clinical study of its Symplicity Spyral renal denervation (RDN) system for hypertension would continue into next year after lacking the positive results needed to end enrollment early. The following month, supply chain and manufacturing issues lead to the announcement that Medtronic’s much-anticipated Hugo surgical robot launch had been pushed off-schedule.
The third setback for Medtronic came last month when the company received an FDA warning letter focused on the inadequacy of specific medical device quality system requirements at its diabetes business’ Northridge, California, facility.
