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A recently recalled Guidant implantable defibrillator has been cleared for re-launch in the U.S. marketplace now that a new switch for the device has been approved by the FDA, the company announced early last week.
European regulators have given medical devicemaker Medtronic CE mark approval to sell its Endeavor drug-eluting stent (DES) system in EU member countries. The device is designed to open patients’ clogged arteries during angioplasty procedures.
Silicone gel-filled breast implants came closer to being marketed again in the U.S. late last month when implant manufacturer Mentor announced it had received an "approvable letter" from the FDA for its MemoryGel implant.
Houston-based devicemaker Cyberonics won a lengthy battle last week when a premarket approval application supplement for its vagus nerve stimulation (VNS) therapy system was approved by the FDA “for the adjunctive long-term treatment of chronic or recurrent depression in adults.” The device has been approved for treatment-resistant depression (TRD) in Europe and Canada since 2001.
Cyberonics CEO Robert Cummins is firing back against negative publicity resulting from a Senate Finance Committee probe into the FDA’s handling of the company’s application to market an existing device to treat patients with major depressive disorders.
AdvaMed has launched a sharp counterattack to an FDA study finding that medical device manufacturers have failed to conduct additional studies required as a condition for obtaining premarket approval of their products.