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.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
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
St. Jude is “feeling really good” about Durata
Medical device maker St. Jude Medical (NYSE:STJ) is feeling pretty confident about public perception of its Durata defibrillator leads, which came under scrutiny amid a high-profile recall of its older Riata leads.
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.
Abbott, Boston Scientific pay almost no taxes in Ireland despite billions in profits | Wall Street Beat
Medtronic’s Endurant II AUI stent graft wins FDA approval
Updated May 30, 2013, at 7:30 p.m. to correct that approval was granted for the Endurant II Aorto-Uni-Iliac stent graft system.
Medtronic (NYSE:MDT) said the FDA granted pre-market approval for its Endurant II Aorto-Uni-Iliac stent graft to treat abdominal aortic aneurysms and clearance for the Sentrant introducer sheath used with the AUI device.
FDA warns CooperSurgical about Texas manufacturing plant
The FDA issued a warning to CooperSurgical (NSDQ:COO) after inspectors noted violations at the company’s Stafford, Texas, manufacturing facility.