Regulatory

Vital Access Corp. has received U.S. FDA market clearance for its patented VWING™ Vascular Needle Guide which has been shown to enable vascular access to arteriovenous fistulas for patients undergoing hemodialysis.

JenaValve’s eponymous TAVI system has seen its CE mark indications extended, making it the only transcatheter valve system approved for the treatment of aortic stenosis and aortic insufficiency.

Ortho/Spine device company Tyber Medical has gained CE Mark approval for TyPEEK, a proprietary titanium plasma sprayed PEEK interbody system. TyPEEK interbody fusion devices are specifically designed for situations where PEEK alone may not provide the best setting for fusion. Tyber Medical is a supplier of private label implants.

Yep, €17.5Bn. That’s the estimate from (admittedly) the European medtech industry, of what a centralised PMA-style regulatory body would incrementally … continue reading “EuroPMA Will Cost €17.5Bn”

W. L. Gore & Associates has gained FDA approval for its Conformable GORE® TAG® Thoracic Endoprosthesis for endovascular repair of acute and chronic Type B dissections of the descending thoracic aorta. This durable endoprosthesis is the only device to receive FDA approval for this indication and is designed for multiple thoracic etiologies.

A couple of weeks ago we were reporting that InVivo Therapeutics was having to come to terms with the FDA’s … continue reading “InVivo’s Woes Increase as Interim CFO Walks After Two Weeks”

Aesthetic medical device company Syneron Medical Ltd., has announced FDA clearance and CE mark approval for VelaShape® III, the Company’s new non-invasive body shaping platform. This new platform is said to be effective for temporary reduction in circumference of the abdomen and is also used in a wide range of other body shaping applications such as cellulite treatments.

Keystone Heart’s clever filter sits over the aortic cerebral branches during TAVR and other interventional heart procedures, preventing debris from heading north. Now the device, developed in Israel, has gained CE marking and will now be introduced into Europe.

Apica Cardiovascular has received CE Mark Approval for its platform Access, Stabilisation, and Closure (ASC™) system that allows for the delivery of aortic and mitral valves through the chest wall and apex of the beating heart

Hemasorb Plus is provided ready-to-use and achieves hemostasis by mechanical tamponade. Its proprietary formulation is comprised of granular hydroxyapatite/beta-tricalcium phosphate and water soluble components that are fully synthetic and absorbable.

Newly CE marked, Pantheris is the first-ever lumectomy catheter for image-guided atherectomy to treat patients with Peripheral Artery Disease.

Back in May, Stryker issued an Urgent Medical Device Recall requesting medical facilities to examine their inventory of five product … continue reading “FDA Class I Recall for Stryker Spine’s OASYS Midline Occiput Plate”

Rapid detection of Multiple Myeloma has to be a good thing, as this particular cancer deteriorates rapidly and has a poor prognosis. So the newly announced CE mark approval of a device that can do in ten minutes what currently takes ten days sounds like a guaranteed win.

SpineGuard has received FDA 510(k) clearance of three new products that complete its PediGuard platform of single-use drilling instruments which secure the pedicle screw pilot hole: Two miniaturized versions of its classic and curved range, and a directional version of its cannulated series.

Spinal implant developer LDR has gained U.S.FDA approval for use of its Mobi-C device two-level indications, making it the first and only cervical disc in the United States approved to treat more than one level of the cervical spine.

Dallen Medical has received FDA 510(k) clearance for a polymer-coated version of its Compressyn™ Band for sternal closure. This clearance follows earlier clearances for its non-coated Compressyn Band and the company’s Compressyn Staple for foot, ankle & hand fixation and repair.