Varian Medical Systems (NYSE:VAR) is touting a pair of regulatory wins for the next generation of its Vitesse brachytherapy treatment for prostate cancer.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Cerebral Palsy: Bioness touts FDA win for treatment of foot drop in children
Valencia, Calif.-based neurostimulation devices maker Bioness Inc. won the FDA’s OK for its L300 Foot Drop system, the 1st FDA-cleared device of its kind for treating children suffering from foot drop as a result of cerebral palsy or other brain injuries.
The L300 neurostimulation device, which is available for sale immediately, "sends low-level electrical stimulation to the nerves in the lower leg which control the muscles responsible for lifting the foot," according to a prepared release.
FDA seeks to downgrade regulatory oversight of scleral plugs
FDA officials this week issued a proposed rule that would downgrade the regulatory status of scleral plugs, devices used to temporarily close incisions made in the eye during surgical procedures.
The federal watchdog agency concluded that pre-market notification, or a 510(k) submission, is unnecessary to determine the safety and effectiveness of the devices, so long as they are made of surgical grade stainless steel with or without a gold, silver or titanium coating, according to a report in the Federal Register.
Gore wins CE Mark for lower-profile stent-graft components
Arizona medical device maker W.L. Gore & Assoc. announced CE Mark approval in the European Union for new components of its Gore Excluder AAA endoprosthesis in treatment of abdominal aortic aneurysms.
European regulators cleared Gore’s lower-profile 31 mm diameter ipsilateral leg and 32 mm aortic extender, designed for use with the Excluder AAA stent-graft in sealing off aneurysms and creating new paths for blood flow.
Teleflex lands FDA win for Arrow UltraQuik needles
Bausch + Lomb lands Class I recall status after broken syringes harm patients
Eye care giant Bausch + Lomb received the FDA’s highest-risk classification for a recall of several lots of sterile cannulas after a few patients were seriously injured with the small tubes detached from syringes during injection.
The FDA gave the recall Class I status, generally reserved for recalls which "involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the FDA notice.
FDA abandons off-label marketing protection ruling
Government officials decided this week not to pursue appeal of a judge’s decision to protect a salesman’s off-label activities as part of his right to free speech, a ruling that may put a kink in the FDA’s efforts to curtail inappropriate medical device and drug marketing.
A New York court late last year overturned a lower court’s ruling against Alfred Caronia, who was convicted in 2009 for illegally marketing narcolepsy drug Xyrem for uses that weren’t approved by the FDA.
Stryker shrugs off recall charges in Q4 to end 2012 on target
Medtronic lands new EU indications for Complete SE stent
Medtech titan Medtronic (NYSE:MDT) won new European regulatory consideration for its Complete SE vascular stent, gaining approval for use in the arteries that supply blood to the legs.
Medtronic won CE Mark approval in the European Union for use of the Complete SE self-expanding stent in the superficial femoral arteries and proximal popliteal arteries and announced international launch immediately.
Primer on U.S. FDA’s new 510(k) refuse to accept policy
By Stewart Eisenhart, Emergo Group
1 in 3 metal hips may fail in under 5 years, J&J analysis finds
An internal analysis conducted by Johnson & Johnson (NYSE:JNJ) concluded that 37% of subsidiary DePuy Orthopaedics’ metal-on-metal ASR hip implants would fail within 5 years, according to documents uncovered during a patient injury lawsuit.