Approval/Clearance

Vascular device specialist AngioDynamics, has received FDA 510(k) clearance for the Xcela Plus Port family through its Navilyst company.

St. Jude Medical, Inc. has gained regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and launch of the Accent MRI™ Pacemaker and the Tendril MRI™ lead.

The U.S. FDA has cleared for marketing Rhythmlink’s Disposable MR Conditional Cup Electrodes, the first of a kind to be formally authorized for use.

Edwards Lifesciences Corporation, is trumpeting the news that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the Edwards SAPIEN XT valve, making it the country’s first commercially available transcatheter aortic heart valve.

Medtronic, Inc. has announced the first patient enrollments in the U.S. Overnight Closed Loop Study, a key feasibility trial to begin the commercialization path for a third-generation, fully automated artificial pancreas system for people with diabetes.

St.Jude Medical, Inc. has received CE Mark approval of its next-generation quadripolar device, the Quadra Assura MP™ cardiac resynchronization therapy defibrillator.

EndoChoice has announced the FDA clearance of its clever Fuse endoscope system, which it claims allows doctors to see around … continue reading “Newly Cleared 3 Camera “Fuse” System Reduces Adenoma ‘Miss Rate’ During Colonoscopy”

CryoLife, Inc. has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the US FDA. PerClot is an absorbable polysaccharide hemostat, intended for adjunctive use in surgical procedures when control of capillary, venular, and arteriolar bleeding by pressure, ligature, and other conventional means is ineffective or impractical.

Abyrx, Inc., a privately-held therapeutic device company, has announced the US FDA Clearance of its new Absorbable Hemostatic Bone Putty (AHBP) for clinical use in the country. The company says this is new product shows it’s offering a vertically integrated product strategy.

FDA clearance for Verasense means it’s the first intraoperative system to market that combines quantifiable limb alignment and soft tissue balancing for surgeons during total knee arthroplasty.

Aesthetic Breast expert Mentor Worldwide LLC, has announced the U.S. FDA approval of its MENTOR® MemoryShape™ Breast Implants, providing new options for women looking for a more natural shape and youthful feel from breast enhancement or reconstruction surgery.

California-based Reverse Medical Corporation has announced the initial clinical use of its MVP™ Micro Vascular Plug system for peripheral artery embolization. … continue reading “CE Mark And Clinical Use For MVP™ Micro Vascular Plug In Peripheral Embolization”

Codman Neuro has announced the gaining of CE mark approval for its self-expanding clot removal device. The Revive SE nitinol basket for removal of clots in the treatment of ischemic stroke features newly enhanced navigation which should speed up restoration of blood flow.

J&J Company, Cordis Corporation has received FDA clearance of its latest innovation in guiding catheters: the ADROIT™ 6F Guiding Catheter, which the company says means easier advancement of devices, with its 0.072′ diameter, the largest inner diameter of any guiding catheter in the U.S. .

Medtronic, Inc. has announced the CE Mark and the European launch of its ReDuX™ Plier, a new instrument specially designed … continue reading “Newly CE Marked Medtronic ReDuX™ Plier Facilitates Osteotomies in Spinal Deformity Surgeries”

Angioplasty catheter developer, AngioScore, Inc., has announced the FDA approval of a Pre-Market Approval Supplement (PMAS) labeling change allowing inclusion of a summary of the AGILITY Coronary Bifurcation Trial results in the AngioSculpt® PTCA Scoring Balloon Catheter Instructions for Use (IFU).