Regulatory

Precision Spine has received 510(k) clearance from the FDA on November 20, 2012 for its Mini-Max Minimally Invasive Access System.

The U.S. FDA has cleared Angiotech’s Bio-Seal Lung Biopsy Tract Plug System, a device that seals punctures left by biopsies performed to confirm a diagnosis of suspected lung conditions.

Zimmer Spine, Inc. is initiating a voluntary worldwide recall of all 315 units of the PEEK Ardis® Inserter because of reports of implant breakage when the implant is subjected to excessive lateral and/or off-axis forces from the inserter during surgery.

Previously Ascendx Spine only had FDA clearance for its vertebral body excision device. Now it’s all systems go for commercialisation, as the rest of the system gets the nod.

A new liposuction cannula that avoids the traumatic sawing action employed during fact removal seems like a good idea. Now it’s gained FDA clearance.

We’re never quite sure about the sense behind this HDE regulation. It seems to allow products onto the market as staging posts for later broader approval, making the initial limited audience look a bit like guinea pigs.

Insulet Corporation, has gained 510(k) clearance to market what it’s calling the “next-generation” OmniPod® Insulin Management System, more than a third smaller and a quarter lighter than the original model

Devicor® Medical Products, Inc. has announced that the US FDA has approved Mammotome® revolve™, a dual vacuum-assisted biopsy system, for use on patients.

Ethicon, a division of J&J, has identified an issue in the packaging process for its SurgiFlo haemostatic matrix. It seems certain products, manufactured between September 16 2011 and July 27 2012 are susceptible to a potential breach of the double Tyvek pouch of the packaging.

Paris-based ultrasound therapy specialist, Theraclion, has gained CE mark approval for its non-invasive treatment of breast fibroadenomas, a first in this indication. The company expects this treatment to benefit thousands of women.

UK device company Microsulis Medical Ltd, specialist in minimally invasive, microwave ablation technology for the coagulation of soft tissue, has received FDA clearance for its upgraded Accu2i pMTA applicator.

Nexstim’s Navigated Brain Therapy (NBT) System has gained CE mark clearance, becoming the first non-invasive, non-systemic therapeutic device CE-marked to offer patients a personalised treatment for major depression and stroke rehabilitation.

German trauma device company aap Implantate has announced that the first six systems of the Loqteq® Trauma Plating family of products has gained FDA 510(k) clearance. The company says it will commence commercialisation early in the new year.

Iridex Corporation has gained FDA 510(k) and CE clearance of the TxCell Scanning Laser Delivery System which it says saves significant time in a variety of laser photocoagulation procedures in allowing physicians to deliver the laser in a multi-spot scanning mode, rather than the traditional single spot mode.

Merit Medical, Inc., has a new FDA 510(k) clearance to trumpet: Merit’s ONE Snare™ endovascular snare system will see its U.S. launch in January

Ah, that’s a clever idea. Attach an inferior vena cava filter to a central line and you can protect patients for whom anticoagulation is not an option, against the threat of venous thromboembolism. Following CE marking BiO2’s Angel™Catheter is being launched in Europe this week.