Medical device recalls for March 2014
April 2, 2014 by MassDevice staff
March Summary
Class I recalls: 10
Class II recalls: 183
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall Read more
FDA approves St. Jude Medical's Protégé spinal cord stimulator
April 4, 2014 by Brad Perriello
St. Jude Medical said it won pre-market approval from the FDA for its Protégé spinal cord stimulator for treating chronic pain, calling it the 1st neurostimulation system equipped for upgrades without surgery.
The Protégé device is designed to alleviate chronic pain after traditional treatments have failed, by interfering with the transmission of pain signals using electrical pulses, according to a press release. The upgrade feature gives patients implanted with the Protégé access to “therapies, stimulation modes, diagnostics or other features once approved through future software upgrades,” according to the release, without the need to surgically replace the device. Read more
Going global: New AdvaMed chairman Almeida's focus on medtech harmony around the world
April 2, 2014 by Arezu Sarvestani
Incoming AdvaMed chairman Jose Almeida has an international outlook, planning to focus his 2-year leadership tenure on several goals that aim to reconcile initiatives in the U.S. with efforts overseas.
In an conference call with reporters today Almeida, the president & CEO of Covidien, talked about harmonizing regulatory expectations and implementing ethical business standards internationally, while staying the course on efforts to streamline medtech review and to spur corporate tax reform in the U.S. Read more
Sorin wins expanded CE Mark for Perceval aortic valve
April 1, 2014 by Brad Perriello
Sorin Group said it won CE Mark approval in the European Union for adult patients to be treated with its Perceval sutureless aortic valve.
Sorin said the approval expands the addressable patient population from just people over age 65 with with aortic stenosis or steno-insufficiency disease to adults with those conditions. Read more
FDA advisory panelists must disclose conflicts of interest, agency says
April 4, 2014 by Arezu Sarvestani
FDA consultants must make new efforts to disclose their business relationships before serving on advisory panels that help determine whether a new medical device or drug gains access to the U.S. market.
The federal watchdog agency this week put the final touches on new guidance that requires a pair of new forms from prospective advisory panelists. Read more
