DePuy Synthes Spine’s VEPTR/VEPTR II Devices are the first spine devices to have such a change in regulatory status.
Products
FDA Clears World’s First Injectable Wireless MicroSize Pain Relief System
Stimwave Technologies Inc., tells us it has received FDA clearance to market the world’s first wireless, microtechnology neuromodulation device for relief of chronic back and leg pain.
FDA Clears Aer-O-Scope™ 360° Colonoscope System
GI View Ltd., has announced that it has received U.S. FDA 510(k) clearance for its flagship product, the Aer-O-Scope™ Colonoscope System
FDA Clears Benvenue’s Luna® 360 Interbody Fusion System
Benvenue Medical has gained U.S. FDA 510(k) clearance for its Luna® 360 Interbody Fusion System for spinal fusion treatment of symptomatic degenerative disc disease
FDA Clears Supersonic Imagine’s New Musculoskeletal and Vascular Ultrasound Probes
It’s RSNA week, and SuperSonic Imagine is touting the FDA 510(k) clearance for two new probes used with its ultrasound machine, the Aixplorer®.
EndoBarrier® Back on EU Market, with Revised IFU
It seems the suspension of EndoBarrier sales in Europe it was more than just a paper exercise, as vigilance changes have seen it change its indications.
Pentax Medical Launches New VIVIDEO ENT System in EMEA Markets
New Pentax ENT Videoscope Delivers a “Different World” of Image and Illumination
Want to Know Whether Specific Biotronik Implant is MRI Compatible?
Biotronik, is launching ProMRI® SystemCheck, a new online tool for tracking the ProMRI status of implantable devices.
All-In-One Hemodynamic Management Platform Launched by ImaCor
“Our time to stability with ImaCor’s technology has proven to be cutting edge.”
Research Suggests Coronary Stents Market Worth $5.61 Billion by 2020
If you keep a regular finger on the pulse of the coronary stent market you’ll need to decide whether you’ll learn much from these reports, but you pays your money….
New Report Predicts 4.5% EU Medical Technology Market Annual Growth
Titled the Medical Technology Market in Europe 2014-2018, the report forecasts the Medical Technology Market in Europe to grow at a CAGR of 4.50 percent over the period 2013-2018.
Vial of 10 Gelatin Embolization Pledgets FDA Cleared for Tumour and AVM Use.
New Gel-Block 10x offers 10 pledgets in a vial as a configuration that enhances value and customer ease-of-use.
FDA 510(k) Clearance for Philips IQon Spectral CT
Royal Philips’ IQon Spectral CT presents an entirely new approach to spectral imaging, enhanced image quality helping to improve confidence in diagnoses and deliver operational efficiency.
FDA Clears Interventional Spine’s Lateral Opticage Expandable Interbody Fusion Device
The Lateral approach adds to the Interventional Spine® family of Opticage™ Expandable Interbody Fusion Devices previously cleared for TLIF
Covidien Unblocks AV Access Market with FDA Clearance of Fortrex™ PTA Balloon
Covidien plc has gained U.S. FDA 510(k) clearance for its Fortrex™ over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter.
CE Mark for the Covidien’s Latest Nellcor™ Bedside SpO2 Monitoring System
CE Mark approval for Nellcor™ PM100N Bedside SpO2 Patient Monitoring System brings the latest in bedside pulse oximetry to the home healthcare.