(Reuters) — Consumer watchdog Public Citizen said it petitioned the FDA to withdraw approval of Sanofi‘s (NYSE:SNY) Seprafilm and order a recall, saying the surgical implant has been associated with side effects including death. Seprafilm, developed by Sanofi subsidiary Genzyme, is used to reduce abnormal internal scarring following surgery, by separating tissues and organs while they […]
FDA rejects ban on pelvic mesh, supports reclassification
FDA regulators refused this week to ban U.S. sales of pelvic mesh implants, rejecting in large part a petition filed by consumer advocacy group Public Citizen, but offered some consolation in a potential reclassification of the devices to a higher-risk category.
FDA: Safety, efficacy, public health – and economy?
FDA officials and consumer advocates balked yesterday at legislative attempts to alter the federal watchdog agency’s mission statement to include promoting job growth, competition and economic growth.
A U.S. House version of a bill reauthorizing FDA user fees for medical devices and pharmaceuticals would include economic obligations FDA officials said would distract from the agency’s responsibility to patients.
Brain-stim studies tout safety amid battle over stricter FDA standards | MassDevice.com On Call
MASSDEVICE ON CALL — Brain stimulation using electrical currents is a safe and effective depression therapy and may even have other surprise perks for the body, according to research conducted at the University of New South Wales.
More than half of all patients in what researchers called the largest and most definitive study of transcranial direct current stimulation experienced "substantial improvements" after getting the therapy, according to a press release.
Consumer group demands PMA for brain stimulation devices
Consumer advocacy group Public Citizen petitioned the FDA to require a more stringent standard for cranial electrotherapy stimulator devices, after a panel of agency experts recommended that the products not be downgraded to a lower-risk category.
The FDA’s Neurological Devices Panel met last month to discuss whether CES devices need more regulatory oversight, concluding that "since the benefits did not outweigh the risks, the device should be Class III."
Stryker’s Wingspan brain stent gets a date with the FDA
The FDA’s neurological devices panel will review clinical data from trials of Stryker’s (NYSE:SYK) Wingspan brain stent system next month, aiming to address harsh criticisms and public petitions urging the agency to recall the device.
The panel plans to consider pre-market and post-market data about the device, including the Gateway PTA balloon catheter and stent delivery system, to address concerns that Wingspan may lead to heightened risk of stroke or death.
MassDevice.com +3 | Public group vies for Stryker recall, Doc fix extended 2 months, Philips lands HeartNavigator clearance
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This latest feature of MassDevice.com’s coverage highlights our three 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.
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Former CDRH director joins Public Citizen in demanding recall of Stryker’s brain stent
Updated Dec. 22, 2011, at 12:30 p.m. to include comments from Stryker.
Consumer watchdog group Public Citizen asked the federal government to recall Stryker Corp.’s (NYSE:SYK) Wingspan brain stent over concerns that it may lead to heightened risk of stroke and death.
Former CDRH director supports Public Citizen’s petition to recall Stryker’s Wingspan brain stenting system
December 20, 2011
Dear Dr. Wolfe
I write this note in support of your petition to the FDA to withdraw the HDE approval from the Wingspan stent and to request a recall of this device.
Hacker outs Medtronic, five devices to save Steve Jobs, public watchdog demands mesh recall | MassDevice.com +3
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This latest feature of MassDevice.com’s coverage highlights our three 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.
Recall transvaginal mesh, says Public Citizen
Consumer advocacy group Public Citizen urged the FDA to recall transvaginal mesh products after the agency released warnings that the device may expose patients to unnecessary risk without offering clinical benefit above safer options.
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