May 6, 2015 by Mark Hollmer
The FDA is withdrawing 47 draft guidance documents published before the end of 2013 that it never finalized or acted on.
Agency officials posted the announcement in the Federal Register, explaining that the move is designed to boost efficiency and transparency regarding its development of guidance documents. Read more
May 7, 2015 by Scott Wooldridge
When it comes to policy issues, it was good news/bad news for attendees of the 2015 MedTech Investing Conference in Minneapolis.
On the plus side, a panel discussion, “Medtech, the View from Capitol Hill,” saw panelists agreeing that regulation by the FDA had become much more collaborative with medtech, to the point where they were optimistic that the FDA/industry relationship had turned a corner. Read more
May 5, 2015 by Mark Hollmer
Medtronic said it gained 510(k) clearance for 1 spinal repair device and began the commercial rollout of another.
The global medical device giant said that the FDA cleared its Zevo anterior cervical plate system, a spinal fusion device designed to address damage stemming from cervical degenerative disc disease, trauma, tumors, deformity, pseudoarthrosis and/or failed previous spinal fusions. Read more
May 6, 2015 by Brad Perriello
The FDA sent a warning letter last month to Smith & Nephew, flagging problems found during inspections of the plant in Andover, Mass., where the British healthcare giant makes its Truclear Ultra 4.0 laparoscopic power morcellator.
The April 30 warning letter followed inspections in March at the Andover plant, where the federal safety watchdog found 4 problems with the way Smith & Nephew corrects and validates the manufacturing process for the Truclear Ultra device. Read more
May 5, 2015 by Brad Perriello
Medtronic today said the FDA cleared its Euphora semicompliant balloon dilation catheter, and the company wasted no time in getting the pre-stenting device on the U.S. market.
Dr. James DeVries of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., performed the 1st commercial case to use the Euphora device, Medtronic said. It’s designed to re-open a clogged coronary artery to prepare the lesion for a stent, the company said. Read more