Regulatory

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).

Newly cleared AHBP is ready-to-use and achieves hemostasis by mechanical tamponade. Its proprietary formulation is comprised of water soluble and dispersible components that are fully synthetic and substantially absorb within days following surgery.

Micell’s MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System is a thin-strut stent that features elimination of the coating from the stent in 45-60 days and the complete absorption of the polymer coating within 90 days. Uniquely it provides local drug delivery both during and after the period of polymer absorption, thereby eliminating long-term polymer exposure, a potential cause of delayed healing and late adverse events.

An FDA Class I recall has been issued because certain Symbios Pain pumps may have excessively high flow rates with the attendant risk that medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity.

Last month St. Jude Medical, Inc. told us it had gained CE mark approval for its next-generation Ellipse™ and SJM … continue reading “FDA Approval For St. Jude’s Ellipse™ and Assura™ ICD/CRT-Ds”

When Sweden’s device authority called for all PIPs to be removed last week their evidence was seized upon by UK … continue reading “UK Plastic Surgeons Jump On Swedish PIP Results”

TEI Biosciences, Inc. has gained FDA Investigational Device Exemption (IDE) approval to initiate a human clinical trial to gain specific … continue reading “Trial Will Test SurgiMend® PRS Breast Cancer Reconstruction Claims”

Tissue processing and device company CryoLife, Inc.,has gained a CE Mark for its new iteration HeRO (Hemodialysis Reliable Outflow) Graft … continue reading “CE Mark For CryoLife’s New HeRo® Graft”

Cardiac arrhythmia specialist company, Cardiac Insight, Inc., has received US FDA 510(k) clearance for its Stealth™ body-worn ECG monitor

The medical device industry brings life-saving and health-giving technology to the world. The funny thing is that from a global … continue reading “This week’s “View From The Med” blog online now”

GE Healthcare has gained FDA 510(k) clearance for its latest Brivo Plus C-arm, which is now available in the US. The pitch for the newly cleared device is that with legacy OEC image quality and ease-of-use, the affordability and reliability of this new Brivo C-arm will offer a high quality, economically attractive option for basic surgical imaging.