St. Jude Medical (NYSE:STJ) today won FDA approval for the next generation in its portfolio of high-voltage devices, which include safety features that overcome some common problems with implantable defibrillators.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
EndoChoice nabs 510(k) for its Fuse colonoscopy system
EndoChoice got the FDA’s green light for the Fuse endoscopy system, which the company says features numerous improvements over traditional endoscopy technology and will help docs catch more tumors.
The Alpharetta, Ga.-based colonoscopy device maker said its clinical trials demonstrated that Fuse only has a tumor "miss-rate" of 8%, compared with 42% with a traditional device.
When conduct becomes a crime
By: John Roth
In my last post, I explained how FDA’s Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to regulatory action. For Abbott Laboratories and Amgen, the price for regulatory malfeasance was high: $1.4 billion – yes, billion – paid in criminal and civil penalties to the United States.
FDA releases full Edwards Lifesciences warning letter
Boston Scientific warns of labeling issues in balloon dilators, catheters
Hong Kong’s Medical Device Control Office sent out 3 field safety notices warning hospitals and consumers of labeling problems with a trio of Boston Scientific (NYSE:BSX) products: a balloon dilator, a thermoplasty catheter and a balloon catheter kit.
J&J struggles to bring Synthes into the fold | MassDevice.com On Call
MASSDEVICE ON CALL — Michael Orsinger, the J&J executive in charge of the recently formed DePuy Synthes unit, said "less than half of the necessary work" to incorporate Synthes is complete, according to an interview with Swiss business newspaper Finanz und Wirtschaft.
More FDA inspection troubles for Hospira
Cook Medical lands FDA win for Evolution biliary gastrointestinal stent
Medical device maker Cook Medical won FDA clearance for its Evolution biliary stent, the latest in the company’s line of controlled-release stents designed for use in the gastrointestinal tract.
Like the rest of the Evolution line, the newly cleared biliary stent delivery system includes recapture technology that allows physicians to modify the stent’s placement before full deployment.
FDA clears GE Healthcare’s Brivo Plus imaging C-arm
GE Healthcare (NYSE:GE) expanded its Brivo Plus C-arm product line with the OEC Brivo Plus, a device used for basic surgical imaging. The new FDA clearance makes the Brivo Plus the 1st in this line of surgical C-arms sold in the States.
The Salt Lake City, Utah-based company touted the device’s new features, such as advanced clear intelligence imaging, a user-friendly interface and wireless connection.
Intuitive Surgical ships new surgical scissors following crack warning
Intuitive Surgical (NSDQ:ISRG) is shipping a new version of its EndoWrist surgical scissors after last month issuing a warning that an earlier model may develop "micro-cracks" that could result in patient harm.
Women’s health: Swedish regulators recommend preventative removal of PIP breast implants
It’s more bad news for women who received breast enlargement or reconstruction with implants manufactured by French medical device maker Poly Implant Prothèse, as healthcare regulators in Sweden recommended this week that all patients undergo preventative removal of the devices, even those with no indications of problems with the implants.