Approval/Clearance

The UK’s National Institute for Health and Clinical Excellence (NICE) has published new guidance supporting the use of the Exogen device to heal long bone fractures with non-union at 9 months, but uncertainties in the evidence mean the jury is still out on 3 month old non-unions.

Mitral valve repair specialist company NeoChord, has received CE-marking for its technology that allows the implantation of artificial chordae tendinae, a proven technique for the repair of mitral valve prolapse, via a transapical, off-pump procedure.

Early stage orthopedic device company, Soft Tissue Regeneration, has developed a breakthrough tissue engineering platform used to regenerate ligaments and tendons. The company has announced that it has received FDA clearance to market its STR GRAFT, a biodegradable scaffold used for soft tissue augmentation and rotator cuff repair.

Abbott’s XIENCE Xpedition™ Everolimus Eluting Coronary Stent System has received U.S. FDA approval and is to be launched immediately in the United States.

Medical Modeling Inc., has received FDA 510(k) clearance for its innovative VSP® System product line. Initial applications of the technology include products such as VSP® Orthognathics – Applying virtual surgical planning and CAD/CAM surgical splints to the area of orthognathic surgery, and VSP® Reconstruction – Applying virtual surgical planning to the reconstruction of the mandible or maxilla using vascularized grafts from other areas of the body.

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.

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.

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.

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.