Products

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”

DePuy Synthes CMF has announced the U.S. launch of new instrumentation that enables less invasive surgical fixation and stabilization of rib fractures. The MatrixRIB™ System offers precontoured, low-profile titanium plates, locking screws and intramedullary splints.

Cook Medical has a new device which it says simplifies percutaneous nephrolithotomy procedures, during which physicians break up and remove large kidney stones. LithAssist™ combines suction control and provides access for a laser fiber and is the first device globally to provide suction control and laser fiber access.

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

According to global market intelligence company Millennium Research Group, the European market for clot management devices will see moderate growth through 2022. Although a number of segments are mature, fast-growing segments such as endovascular treatments for acute ischemic stroke and venous thromboembolism underpin the growth forecast.

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.

The Medical Care division of Bayer HealthCare is introducing its Jetstream™ Atherectomy System at the next week’s annual meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in Lisbon, Portugal. The device can be used to treat a wide range of vessel diameters and features continuous active aspiration.

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

Royal Philips has chosen the EuroPCR event in its home country, at which to launch of EPIQ ultrasound system. The company claims EPIQ offers an entirely new level of clinical confidence with a first-of-its-kind ultrasound architecture that is a totally new approach to creating ultrasound images without compromise.

Biotronik now boasts one of the longest drug-eluting stents on the market across all diameters with the market release of new 35 and 40 mm versions of Orsiro, the industry’s first hybrid Drug Eluting Stent (DES) featuring a bioabsorbable polymer.

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.