European Clearance for Zimmer/Biomet Deal

It’s taken nearly a year, but the EU cogs have now whirred enough, so the deal is cleared, subject to a commitment to divestitures


FDA Clearance for Wright Medical’s External Fixator

The SALVATION™ external fixation system forms an integral part of Wright's Limb Salvage product portfolio

Spinal Fixation System for the Most Complex Spinal Deformities

K2M has received U.S. FDA 510(k) clearance as well as CE mark approval for its NILE™ Alternative Fixation Spinal System, designed to address the most complex spinal deformity cases.

FDA Approval for Impella 2.5 in Elective and Urgent High Risk PCI

With this approval, Impella 2.5 becomes the only FDA-approved percutaneous hemodynamic support device for high risk indications

U.S. Registry Identifies Goldilocks Zone for Joint Replacement Timing

First U.S database yields comprehensive benchmarks for total hip and knee Joint replacement

FDA and CE Mark Approval for Boston Scientific’s Thinner S-ICD System

Boston Scientific will be hoping its new S-ICD will prove popular based on its advantages over conventionally placed leads

New Study Uncovers UK MedTech’s Opportunities and Challenges

Headline imageReport says new regs not a challenge, downward pricing pressure welcome and emerging markets not an opportunity... not really

U.S Study: SAPIEN 3 Beats Mortality Predictions in High and Intermediate Risk Patients

SAPIEN 3 valve demonstrates low mortality, low paravalvular leakage and excellent 30-day outcomes In both patient cohorts

Study Says MitraClip® Offers Mitral Regurgitation Solution to Sickest Patients

MitraClip yields meaningful reduction in regurgitation, thereby offering an interventional alternative when surgery isn't an option

DePuy Synthes Targets Adult Spinal Deformity with Four New Products

Headline imageIt's AAOS week, an event that sees DePuy Synthes touting four new adult deformity products as well as a new education offering

DePuy Synthes Targets Better Hip Fracture Outcomes with New Nailing System

Headline imageA combination of design features and reduced procedural complexity underpin claims for the TFNA Nail, launched at AAOS this week

New Chief Marketing Officer for Pentax Medical

Imaging specialist PENTAX Medical, has announced that its current "President of the Americas", David Woods, has been appointed as the new global Chief Marketing Officer (CMO), effective April 1, 2015.

Turkeys See Christmas as a Challenge

When a new survey of regulatory officers highlights their concerns about regulatory rules, should we be surprised?

FDA Approves Medtronic Protégé™ GPS™ Stent for Iliac Artery Stenosis

Supporting study points to 96% nine month patency and 99% freedom from target vessel revascularization

IDE Study Beckons for Simplify™ Cervical Artificial Disc

It looks like the Simplify Cervical Disc system will soon feature in a U.S. clinical study following FDA's IDE grant

FDA Approves Boston’s WATCHMAN™ Left Atrial Appendage Closure Device

Headline imageFirst-Of-Its-Kind alternative to long-term Warfarin therapy for stroke risk reduction in patients with non-valvular atrial fibrillation