Recalls
Hip Study: Smith & Nephew touts study results for new metal-on-metal implants
British orthopedic titan Smith & Nephew (NYSE:SNN) touted the results of a 10-year study of its metal-on-metal hip resurfacing implants, hoping to differentiate its implants from the high-profile recall of rival DePuy’s ASR device.
Ban metal-on-metal hips, say U.K. researchers | MassDevice.com On Call
MASSDEVICE ON CALL — A team of U.K. researchers is calling for a ban on metal-on-metal hip implants, citing studies that demonstrate that they fail more often than other artificial hips, especially when used in women.
Breast implants: FDA clears new silicon implant despite consumer protests | Regulatory Roundup
MassDevice.com +7 | The top 7 med-tech stories for the week of March 5, 2012.
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
On Medtronic’s most recent medical device “correction”
Yesterday, Medtronic, Inc, the world’s largest medical device manufacturer, notified me in clinic about another problem with one of their lines of defibrillators via a Dear Doctor letter (1 Mbyte) headed by the line "URGENT: MEDICAL DEVICE CORRECTION."
It seems this term is now commonly seen on other Medtronic device advisories as well.
Medtronic warns on battery defect in EnTrust, Escudo ICDs
Medtronic released warnings that a limited number of its EnTrust and Escudo implantable cardioverter defibrillators may have an internal short that may cause the device batteries to deplete prematurely.
The issue affects a small number of implants, less than 0.1% of the global distribution, Medtronic spokeswoman Kathleen Janasz told MassDevice in an email.
GE Healthcare announces layoffs in Vermont | MassDevice.com On Call
Updated March 7, 2012, at 1:30 p.m. with comments from GE Healthcare.
MASSDEVICE ON CALL — GE Healthcare (NYSE: GE) announced another round of layoffs at its South Burlington, Vt., facility, a move it said is a result of declining demand for health care IT and performance solutions businesses.
The move is the "subsequent action" of layoffs numbering around 50 workers at the same facility last month, GE spokesman Corey Miller told MassDevice.
FDA warns Synthes on mishandled device complaints
Synthes landed in more hot water with the FDA, after the watchdog agency tagged it for violations at its West Chester, Pa., headquarters, including failing to promptly investigate and report complaints about potentially malfunctioning devices.
In a warning letter sent Feb. 16 to Synthes president & CEO Michael Orsinger, the FDA chided Synthes for improperly handling customer complaints related to Click’X surgical screws and N-Hance surgical rods.
MassDevice.com +3 | The top 3 med-tech stories for March 6, 2012.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
Steris gets FDA nod to update replacement for troubled System 1 sterilizers
Steris Corp. (NYSE:STE) landed special 510(k) clearance to modify its System 1E sterilizers, the replacement systems for the troubled System 1 devices that were the center of a 2-year row with the FDA.
The Mentor, Ohio-based device maker won the FDA’s approval to update existing SS1E devices in the field with modified software, which will also be applied to all new shipments, effective immediately.