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FDA Nod for Medicrea K-JAWS® Cervical Fixation Staple

Medicrea says its K-Jaws spinal cervical compression staple offers a less invasive and quicker solution than cervical fixation option.


Is Smith & Nephew Really Going all EasyJet in U.S?

Smith & Nephew is to offer a no-frills service to joint customers in the U.S., but what this amounts to other than not having the rep in attendance, is unclear.

Codman Neuro’s New Envoy® Guiding Catheters, Target Access, Support and Stability

Codman Neuro has chosen the SNIS meeting at which to launch the ENVOY® DA XB Distal Access Guiding Catheter and the 7F ENVOY® Guiding Catheter for neurovascular procedures.

FDA Approves Sorin’s Solo Smart™, First Stentless Fully Biological Valve

Headline imageItalian cardiovascular device maker Sorin Group, has gained U.S. FDA approval for the Solo Smart™ Aortic Pericardial Heart Valve which the company claims is the first biological valve to feature a fully removable stent.

Medtronic Boosts Neuro Portfolio with MIS Imaging Acquisition

Medtronic, Inc. has completed the acquisition of Visualase, Inc., and its FDA-approved MRI-guided laser and image guided system for minimally invasive neurosurgery.

Newly Approved Prestige® LP Moves Cervical Disc Game On

Headline imageMedtronic has based its new device on the design principles of its successful predecessor, but a few changes of approach and material represent evolutionary steps.

Covidien Sales Up, But Pelvic Mesh Provision Clobbers Income

Sales ramped 4% compared with the equivalent period a year ago, but an increase in estimates of costs from pelvic mesh products liability cases saw S,G&A expenses ramp.

FDA Clears PicoSure™ for Treatment of Acne Scars

Cynosure, Inc., has received FDA 510(k) clearance for its flagship PicoSure Picosecond Laser Workstation for the treatment of acne scars.

Sorin’s Phospholipid-Reducing Crown Valve Gains CE Mark

Cardiovascular device specialist Sorin Group, has gained CE mark certification for its innovative CROWN PRT™ stented aortic bioprosthesis.

Complex Spine and MIS Line Extensions & Regulatory Clearances for K2M

Headline imageK2M has gained U.S. marketing clearance for its CASPIAN® Occipital Anchor Spinal System and has also announced other product introductions across the globe.

CE Mark for Boston Scientific’s Agent™ Drug-Coated Coronary Balloon

Boston Scientific's Agent™ Paclitaxel-Coated PTCA Balloon Catheter has gained CE mark approval and will now be launched in Europe.

Healthy Sapien Sales for Edwards. Not to Mention that Other $750 Million

Take out the $750 million settlement from Medtronic and Edwards would still be happy with a healthy sales increase over the equivalent quarter a year ago.

FDA Clears 150 cm Arrow® GPSCath® Balloon Dilatation Catheters

Teleflex subsidiary Hotspur Technologies has gained FDA clearance for its 150cm length Arrow GPSCath dual function balloon dilatation catheters.

It May Not Look Like a Lung, But Human Bioemulation is a Reality

Headline imageAnimal testing may soon be a thing of the past if Emulate, Inc., can successfully bring its human bioemulation technology to market.

Perky Sales for AtriCure But Margin Down and Expenses Up Means Losses Increase

Atrial Fibrillation specialist AtriCure, Inc. has announced financial results for the second quarter of 2014.

FDA, Venetian Style

This week we amuse ourselves drawing parallels between the way behaviour was monitored in Venetian colonies during the fourteenth century, and regulation of today's medical device industry.