“Our time to stability with ImaCor’s technology has proven to be cutting edge.”
Regulatory
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.
FDA Clears Avantis Third Eye® Panoramic™ Colonoscopy Device
FDA clears new device for use along with a standard colonoscope to improve visibility in areas behind folds in colon wall.
Cardica Calls Time-Out to Re-Think MicroCutter XCHANGE 30®
Cardica, Inc. is to pull the remainder of the latest iteration of its MicroCutter XCHANGE 30® from sale, drawing a line under the device until a next generation version is ready.
FDA Nod for Allergan NATRELLE® 410 Silicone Breast Implant Range Adds
Allergan, Inc. has announced that it has received approval from the U.S. FDA to market two new styles, X and L, of the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast reconstruction, augmentation and revision surgery.
FDA Clears K2M’s CAPRI™ Corpectomy Cage System
K2M Group Holdings, Inc., has received U.S. FDA 510(k) clearance for its CAPRI™ Corpectomy Cage System, an expandable vertebral body replacement device that provides structural stability following a corpectomy or vertebrectomy.
Titan’s Endoskeleton is First FDA Cleared Nanotech Surfaced Interbody Fusion Device
Spinal interbody fusion device maker, Titan Spine has received U.S. FDA 510(k) clearance from for its Endoskeleton® line, featuring nanoLOCK™ surface technology.
FDA Clears Zimmer’s Optio-C® Anterior Cervical System for use with Structural Allograft/Autograft
Zimmer says its Optio-C System is a next-generation, modular stand-alone cervical device that offers allograft/autograft and PEEK options and delivers the strength, stability and fusion potential of a traditional ACDF
CE Mark for Cardiovascular Systems’ Stealth 360® Peripheral Orbital Atherectomy System
CSI’s Stealth 360 Peripheral Orbital Atherectomy System CE Marked and made available for Europe’s peripheral artery disease sufferers.
FDA Clears Covidien HawkOne™ Directional Atherectomy System for Peripheral Arterial Disease
Covidien says the HawkOne™ System strengthens its directional atherectomy platform with a versatile solution for the treatment of peripheral arterial disease.
Medtronic Points to Improved Deliverability with EU Launch of Resolute Onyx™ DES
First and Only DES with Novel CoreWire Technology Allows for Thinner, Stronger Struts, Enhanced Deliverability and Radiopacity without Compromising Structural Strength
FDA Clears PicoWay Picosecond Laser For Tattoo Removal
20% of folk want to remove their tattoos, thereby creating a market for technology that achieves this aim. Syneron’s newly FDA cleared laser device obliges.