Cianna Medical wins FDA nod for breast surgery device
December 11, 2014 by Mark Hollmer
Cianna Medical said it reached a new milestone, winning FDA clearance for new surgical guidance tech designed to boost precision in breast biopsies and lumpectomies. Plans call for a slow rollout, with a gradual expansion in 2015 beyond 2 medical centers in Florida and Tennessee currently involved in a pilot study, the company said.
“We believe it has the potential to reduce surgical delays, improve patient satisfaction and optimize surgical planning,” CEO Jill Anderson said in prepared remarks. Read more
St. Jude Medical wins CE Mark for Quadra Allure MP pacemaker
December 11, 2014 by Brad Perriello
St. Jude Medical said today that it won CE Mark approval in the European Union for its Quadra Allure MP cardiac resynchronization therapy pacemaker, touting it as the world’s 1st to offer multi-point pacing.
The technology allows physicians to pace multiple locations on the left side of the heart to optimize CRT pacing using St. Jude’s 4-electrode Quartet LV lead, according to a press release. Read more
Medtronic wins FDA approval for more Attain Performa quad defib leads
December 11, 2014 by Brad Perriello
Medtronic said today that it won pre-market approval from the FDA for another pair of its Attain Performa defibrillator leads, designed for varying vessel sizes and curvatures.
Medtronic said the Attain Performa S-shaped and straight leads are meant for its Viva Quad XT and Viva Quad S CRT-Ds. Read more
FDA postpones panel meeting for VertiFlex's Superion spine device
December 10, 2014 by Brad Perriello
The FDA postponed a meeting of 1 of its advisory panels that’s slated to review the pre-market approval application for the Superion spine implant made by VertiFlex.
The FDA’s orthopedic & rehabilitation devices panel was originally scheduled to convene Dec. 12, but the federal watchdog agency yesterday said will delay the hearing until Feb. 20, 2015. No reason was given for the postponement. Read more
Report: FDA doesn't disclose most adviser's ties to medtech
December 9, 2014 by Brad Perriello
Although more than ⅓ of the 122 doctors who sit on FDA advisory panels for medical devices received some form of compensation from medtech companies, the federal watchdog agency only discloses a fraction of those links, according to the Wall Street Journal.
Members of the panels, which evaluate devices used in cardiology, gynecology and orthopedics for the FDA, received compensation including consulting fees, research grants, food, travel and lodging from medical device makers from 2012 through this year, according to the newspaper. But those payments or gifts are not usually disclosed by the agency, the Journal reported. Read more