Approval/Clearance

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.

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.

Zimmer’s PSI Shoulder utilizes 3D visualization software to allow a surgeon to create a customized surgical plan for each patient, and then provides patient-specific surgical instrument guides to facilitate placement of the implant corresponding to the plan.

Theradome™ Inc has seen its LH80 laser helmet gain FDA’s clearance, bringing a so-called “clinical strength” therapy to the home for a fraction of the cost of visiting a hair restoration clinic.

The FDA has cleared Novo Nordisk’s novel NovoPen Echo, the first insulin injection device to combine half-unit dosing with a memory function to help patients better manage their diabetes

InSightec Ltd, a leader in MR guided Focused Ultrasound therapy, announced that its ExAblate system has received approval of Health Canada for MRgFUS treatment of uterine fibroids and for pain palliation of bone metastases.

Intuitively one can imagine a device that delivers semen directly to the cervical opening, might just work. Now that “The Stork” has gained CE mark approval it seems the European authorities buy the story too.

Reverse Medical Corporation has gained FDA clearance for US commercialization of its MVP™ Micro Vascular Plug system for peripheral artery embolization, and the first US clinical cases.

Boston Scientific Corporation continues to expand its electrophysiology (EP) offerings with U.S. FDA approval of its IntellaTip MiFi™ XP catheter and 510(k) clearance of its Zurpaz™ 8.5F steerable sheath. The company says these products join its growing portfolio of next generation EP tools designed to redefine ablation technology.

AngioDynamics, Inc. has announced the U.S. FDA 510(k) clearance through its subsidiary business Navilyst Medical Inc., for its BioFlo Port with Endexo technology, which is designed to reduce the accumulation of catheter-related thrombus on, and in, the port catheter.

CoAlign Innovations, Inc. has announced that its AccuLIF® XL lateral expandable interbody fusion devices have received marketing clearance from the U.S. FDA. This new product line addresses spinal fusion procedures employing the lateral approach.