Prolific spinal device company K2M, Inc., has announced the global expansion of its breakthrough Rail 4D™ Technology at the 2012 North American Spine Society (NASS) Annual Meeting in Dallas, Texas. The technology is said to address the most complex spinal curves.
meddevice
FDAnews Announces Medical Device Mobile Apps Virtual Conference Rebroadcast
Here’s a Virtual Conference Rebroadcast on a proposed bill requiring the FDA to establish an Office of Mobile Health to help speed the development and approval of device apps.
NeuroSigma’s Monarch eTNS System to be Unveiled in London
NeuroSigma, Inc., a Los Angeles-based medical device company, announced today that its Monarch™ eTNS™ system for the adjunctive treatment of epilepsy and depression will make its debut at the 10th European Congress on Epileptology, which takes place in London, England from September 30 to October 4, 2012.
Intelomed Receives FDA 510(k) Clearance For CVInsight Medical Device
Intelomed, Inc., has announced that it has received FDA 510(k) clearance for its CVInsight medical device which measures and displays vital information such as functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate of adult and pediatric patients.
BD’s New Needle Technology Eases Pain For Diabetics
BD Ultra-Fine™ Nano 4mm Pen Needles with PentaPoint™ Comfort are first to feature patented 5-bevel needle tip able to penetrate skin more easily for patients who require insulin injection
Olympus Introduces World’s First And Only Monopolar, Disposable Tonsil Adenoid Debrider
The Olympus DTAD includes 3 industry firsts in one device combining monopolar energy, a battery-powered debrider, and a malleable shaver blade that can be set at 40 degrees for adenoids, 15 degrees for tonsils, or anywhere in between.
Did I get It All? Study Says Yes As MarginProbe® Accurately Identifies Cancer Tissue In Prostate Cancer Surgery
A new study demonstrates the potential for use of Dune Medical’s MarginProbe system in surgical margin assessment during radical prostatectomy procedures.
FDA Clears Covidien’s LigaSure™ Small Jaw Sealer/Divider For ENT Use
Covidien has announced that it has received 510(k) clearance from the U.S. FDA for its LigaSure™ curved, small jaw, open sealer/divider surgical instrument to be used in ear, nose and throat (ENT) procedures.
Biodegradable Metal? But (Hopefully) Not Like My First Car
Combine the strength of steel with the absorption characteristics of a polymer like PLLA and you may have a new category of implant material. So hopes Bio DG which has just been granted a patent in the area.
Cook Showcases New Otolaryngology/Head and Neck Surgery Division At Congress
Cook Medical’s new Otolaryngology/Head and Neck Surgery clinical division is the company’s tenth business unit and is showing its new ideas to the specialty at this week’s AAO-HNS conference in Washington, D.C.
SinuSys Gains CE Mark for AerOs™ Sinus DiIation System And Noses Towards U.S Clearance
Sinus health company SinuSys Corporation, has announced that it has received CE Mark for its AerOs™ Sinus Dilation System. AerOs is designed to gently open the sinus ostia, thereby restoring natural sinus drainage and ventilation using a simple, two-step interventional approach.
ConvaTec To Acquire Intermittent Catheter Provider
ConvaTec says it has entered into a definitive agreement to acquire all of the capital stock of 180 Medical Holdings, Inc. for $321 million. 180 Medical is a leading U.S. provider of disposable, intermittent catheters and urologic medical supplies.
FDA 510(k) Clears Zynex’s InWave Female Urinary Incompetence Device
Zynex, Inc., a provider and developer of non-invasive medical devices for electrotherapy, stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced that it received FDA 510(k) clearance on its InWave medical device which is designed to aid in the treatment of female urinary incompetence.
Cook Medical Opens New $19M U.S. Medical Device Manufacturing Plant
This is what targeted investment in a community looks like, as Cook Medical and its parent Cook Group adds a new manufacturing facility to Canton Illinois, having already built one two years ago… and a boutique hotel! Little wonder the company feels it has the moral high ground as it fights the Government’s new medtech tax plans.
FDA Clears First Vascular Access Product With BioFlo Technology To Reduce Catheter-Related Thrombus
Vascular access device company, AngioDynamics Inc., has announced the U.S. FDA has granted 510(k) clearance for its BioFlo peripherally inserted central catheters (PICCs) with Endexo technology which the company says is designed to reduce the accumulation of catheter-related thrombus on, and in, the catheter.
510(k) For iDrive™ Ultra Powered Stapling System Puts Smile Back On Covidien’s Face
Covidien says its newly FDA cleared device is the world’s only fully powered reusable surgical EndoStapling platform and claims it sets new standards in precision during surgery.