Regulatory

J&J subsidiary, Cordis Corporation has announced that the U.S. FDA has approved its S.M.A.R.T.® CONTROL® Vascular Stent Systems for use in the superficial femoral artery and/or the proximal popliteal artery.

Medtronic’s Valiant Thoracic Stent Graft has become the second device to be FDA approved for use in all descending thoracic aortic aneurysms without dissections.

A new steroid-releasing implant for the treatment of chronic sinusitis has gained the FDA nod and will be available across the U.S. shortly.

Halt Medical, Inc. announced today at the opening session of the AAGL Global Congress on Minimally Invasive Gynecology that the FDA has cleared Acessa™, a revolutionary new medical technology for treating millions of women suffering from uterine fibroids.

When’s an approval not an approval? When it’s an “approvable” of course! LDR’s Mobi-C mobile bearing cervical prosthesis “could” be approved for both one and two level applications. It’s not approved “yet”, but it soon could be. It’s already approved in Europe by the way.

In an interesting and authoritative update from last week’s RAPS regulatory convergence conference in Seattle, medicaldeviceslegal.com’s Erik Vollebregt has laid out the bare facts about one of the key post-PIP measures discussed during 2012.

Spinal device company X-spine Systems Inc. has announced two new U.S. FDA clearances for its products: The Fortex ™ CoCr Rod System and the Certex™ Cervico-thoracic Fixation System.

Medical device regulation is like a colander. It will catch most of what you want it to catch, but every so often a bit of spaghetti slips through the hole. A UK parliamentary committee has decided we must plug all the holes right away, which brings us to question the function of the thing in the first place.

Accuray company, today announced that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new CyberKnife M6(TM) Series. The CyberKnife M6 Series features expanded clinical capabilities, reduced treatment times and an enhanced patient experience.

Smiths Medical’s newly CE marked safety IV product helps protect clinicians and healthcare workers from unintended needlesticks.

Do a handful of medical device failures, and the existence of a tougher regime in the U.S. mean EU device regs are scandalously weak? Well, probably yes, but we already know that. Still, no harm in revisiting it in the interest of , er, what exactly?

Boston Scientific Corporation has announced CE Mark approval for the Synergy™ Everolimus-Eluting Platinum Chromium Coronary Stent System featuring its ultra-thin abluminal bioabsorbable polymer coating which holds the promise of reducing late adverse events.

Thermedical™, a medical equipment company developing new tissue-ablation therapies, has received U.S. FDA clearance to market its innovative technology for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, has announced that it has received approval from the U.S. FDA for the first of four modules of the Company’s PMA filing plan for its TissuGlu®Surgical Adhesive product.

Blue Medical, the global medical device company and innovator in the treatment of vascular diseases, today announced receiving the CE mark for Protégé NC, a non compliant drug eluting balloon.

Maquet Cardiovascular LLC says the approval of its new larger-volume, fibre-optic IAB catheter will allow clinicians to provide a higher-efficacy IAB counterpulsation therapy “at the speed of light” to smaller patients those who are 5’0″ to 5’4″ tall (152-162 cm).