Hospira (NYSE:HSP) heard from the FDA’s inspection office this week with another warning that the infusion device company’s India facility still contains significant violations of good manufacturing practice regulations.
Food & Drug Administration (FDA)
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.
MedWatch: Improving on 20 Years of Excellence
By Margaret A. Hamburg, M.D.
This week FDA is proudly commemorating the 20th anniversary of MedWatch, a program which collects and reviews reports from health professionals and consumers about possible problems with drugs, medical devices and other products regulated by FDA.
FDA clears Echosens’ non-invasive liver diagnostic system
The 510k clearance for Echosense marks the last major market to approve the FibroScan device. The Paris, France-based medical device company first introduced the FebroScan in Europe in 2003, and it has since won approvals in 70 countries.
FDA analysis: 510(k) is here to stay, says medtech attorney
The FDA’s less-stringent 510(k) medical device review pathway is no stranger to criticism, but it has at least 1 fan – Hyman, Phelps & McNamara attorney Jeffrey Shapiro.
Shapiro defended the fast-track review pathway, which doesn’t usually require that medical device companies submit to U.S. clinical trials in order to demonstrate safety and efficacy, and he expects that the 510(k) system will "be around for a long time."
FDA and MDMA: Moving Forward Together
Medtronic’s Pacific Plus PTA catheter gets green light in U.S. and E.U.
Medical device recalls for May 2013
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Relievant lands FDA green light for clinical trial of Intracept back pain therapy
Relievant Medsystems won FDA investigational device exemption for its Intracept back pain therapy, paving the way for the medical device company to continue its SMART pivotal clinical trial.
The Redwood City, Calif.-based company said it will expand the 200-patient randomized, controlled trial to 20 sites across the U.S., where it will evaluate the Intracept therapy in treatment of chronic low back pain.
FDA and device companies butt heads on overseas trial proposal | MassDevice.com On Call
MASSDEVICE ON CALL — The medical device industry has a few qualms with the FDA’s latest proposal to add a layer of ethical review to clinical studies conducted overseas.
Medtech industry lobbying group AdvaMed commended the FDA and generally lauded the agency’s efforts to promote principals of "Good Clinical Practice" in international clinical trials, but warned that certain of the FDA’s proposals may butt heads with rules governing medical information in other countries.