FDA guides on custom devices
September 25, 2014 by Alexander Soule
The FDA yesterday released its final recommendations for legal exemptions for customized medical devices that deviate from already-approved systems by being tailored to the special needs of up to 5 patients.
Examples of such devices might include implantable devices like artificial discs or surgical screws for very tall people or infants that are otherwise unavailable in the correct size. Read more
FDA approves Gore's Viabahn for peripheral stent repair
September 26, 2014 by Alexander Soule
W.L. Gore & Assoc. said the FDA granted pre-market approval for a new indication for its Viabahn endoprosthesis, to treat failed bare-metal stents in the peripheral vasculature.
The Viabahn device 1st won an FDA nod in 2005 for treating femoral artery lesions. A string of expanded indications has followed, including the most recent approval for treating in-stent restenosis in the superficial femoral artery, Gore said. Read more
Alcon wins date with FDA panel for AcrySof lens
September 26, 2014 by Alexander Soule
Alcon Laboratories won a date before an FDA advisory panel in November to review the data behind its application for a new indication for its AcrySof IQ ReSTOR intraocular lens, the watchdog agency said today.
The AcrySof IQ ReSTOR lens is already approved in the U.S. to treat presbyopia and cataracts. Read more
FDA seeks public input on medtech hacking | MassDevice.com On Call
September 24, 2014 by Arezu Sarvestani
The FDA announced that it will hold a public meeting in October to discuss cybersecurity in medical devices.
Co-hosted with the Dept. of Homeland Security, the 2-day summit will bring together a variety of healthcare stakeholders to discuss areas of vulnerability and best approaches to shoring up the digital defenses of medical systems. Read more
ReFlow Medical wins CE Mark for crossing catheters
September 26, 2014 by Alexander Soule
ReFlow Medical said physicians in Germany are already using its Wingman35 and Spex crossing catheters, after the San Clemente, Calif.-based company won CE Mark approval for both devices for treating lesions in the peripheral vasculature.
ReFlow Medical’s Wingman35 extensible tip catheter is designed to gently create a passage to help guidewires cross obstructions in blood vessels. The speX catheter can be shaped to allow physicians to achieve a preferred angle during a procedure, according to a press release. Read more