FDA yanks enhancement reporting requirement
October 15, 2014 by Brad Perriello
The deletion of a single sentence from the FDA’s final guidance on distinguishing medical device recalls from product enhancements eliminated a sore bone of contention between the watchdog agency and the medtech industry.
In February 2013 the FDA proposed to require medical device companies to report any “product enhancement” intended to reduce health risks, even if the move isn’t part of a safety-related recall. Read more
FDA approves Medtronic's full-body MRI-safe lead
October 14, 2014 by Brad Perriello
Medtronic said today that the FDA approved its CapSureFix Novus MRI SureScan 5076 lead in MRI scans for patients with a Medtronic dual-chamber MR-conditional pacemaker.
The 5076 lead was already approved for use with Medtronic’s non-MR-conditional pacemakers, according to a press release. The new approval allows the lead to be paired with the Minneapolis-area medical device giant’s Advisa MRI or Revo MRI SureScan pacemakers. Read more
FDA strikes out again in Prevor drug-or-device case
October 16, 2014 by Val Kennedy
A federal court has again ruled against the FDA’s definition of what constitutes a “medical device” versus a “drug” in a long-running case involving a market application submitted by France’s Prevor for its industrial skin-cleaner DSW.
Last month, the U.S. District Court for the District of Columbia rejected for a 2nd time the FDA’s classification of DSW as a drug, remanding the matter again to the agency for further action. Read more
Abbott inks co-distribution deal with Carl Zeiss Meditec
October 17, 2014 by Brad Perriello
Abbott said today that it inked a deal with Carl Zeiss Meditec that will see it sell Zeiss cataract surgery products alongside its own such offerings in the U.S.
“This comprehensive offering, including synergistic diagnostics, visualization systems, lens extraction systems, and intraocular lenses, provides surgeons with access to a complete cataract surgery portfolio to assist them in maximizing visual outcomes and streamlining patient flow,” Abbott said in a press release. Read more
Boston Scientific wins CE Mark for Accolade MRI-safe pacemakers
October 17, 2014 by Brad Perriello
Boston Scientific said it won CE Mark approval in the European Union for its Accolade line of MRI-safe pacemakers, touting the devices as the 1st to allow full-body MRI scans in both 1.5 Tesla and 3.0 Tesla systems when used with its Ingevity leads.
The Accolade devices also feature Boston Scientific’s ImageReady technology, designed to allow more flexible MRI options, higher energy scan sequences and a programmable MRI timer, according to a press release. Read more
