NeuroSigma gained the European CE mark for its Trigeminal Nerve stimulation system in 2012. Now the Australian TGA has given the device its approval for use in adjunctive treatment of drug-resistant epilepsy.
Approval/Clearance
FDA Approves Abbott’s Supera® Stent to Treat People with Peripheral Artery Disease
Abbott’s Supera® Peripheral Stent System has received U.S. FDA approval to treat people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD). PAD occurs when fat and cholesterol buildup causes arteries outside of the heart to narrow, which reduces blood flow to parts of the body, most commonly the legs. The disease affects 12 to 20 percent of Americans age 65 or older and can cause leg pain, in addition to increasing the risk of heart attack or stroke.
FDA Clears Three New Digital Angiography Systems from Shimadzu
Shimadzu Medical Systems USA has announced that its new digital angiography system family has received FDA 510(k) clearance. The family comprises the ceiling-mounted Trinias, the floor-mounted Trinias, and the Biplane models.
FDA Clears Next Generation Medigus Muse™ System for GERD Threatment
Israeli medical device company Medigus Ltd. has gained U.S. FDA 510(k) clearance for its next generation MUSE™ system, formerly known as the SRS™ system. Muse is a device which enables an incisionless procedure by performing an anterior partial fundoplication with standard surgical staples in a less invasive way.
FDA Approves St. Jude’s Allure Quadra™, Assurity™ and Endurity™ Devices
St. Jude Medical, Inc. has announced approval from the U.S. FDA for the Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P), which provides additional pacing innovations for physicians to treat patients with heart failure. The company also announced FDA approvals for the Assurity™ pacemaker and Endurity™ pacemaker families of devices.
CE Mark for New “Remote Monitoring” ECG Devices
Israeli heart monitoring company, Aerotel Medical Systems has received the CE Mark approval for its new ECG devices, HeartView P12/8i and HeartView 12L.
CE Mark and EU Launch for St. Jude’s Prodigy Spinal Cord Stimulation System with Burst Technology
St. Jude Medical, Inc. has seen its Prodigy™ Chronic Pain System with Burst Technology gain CE Mark approval, which it says will be followed by European launch.
FDA Clears ProTom’s Radiance 330® Proton Therapy System
Proton Beam Therapy specialist company ProTom International, Inc. has announced that it has received U.S. FDA 510(k) clearance for its Radiance 330 Proton Therapy System.
CE Mark for Medrobotics® Flex® System Means MIS Access to Hard-to-Reach Anatomy
Medical robotics company (the clue’s in the name) Medrobotics Corp., has gained the CE mark for its Flex® System and will initiate a limited commercial launch of the product in select European markets.
FDA Clears Volcano’s Proprietary iFR® Modality, Opening Door to Reduced Hyperemic Drug Infusion
Volcano Corporation a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced FDA clearance of its proprietary instant wave-Free Ratio™ or iFR® Modality.
Newly Cleared eZono 4000 tablet Ultrasound System Takes Guesswork out of Ultrasound-Guided Techniques
German ultrasound expert, eZono AG has received FDA 510(k) clearance for its eZono 4000 dedicated procedural guidance system with eZGuide technology, providing “any plane” freehand navigation.
CE Mark for Morph AccessPro™ Steerable Introducer Means Easier Access to Complex Vasculature
BioCardia®, Inc. has gained CE Mark approval for its Morph AccessPro™ Steerable Introducer, designed for easier navigation through the vasculature during delivery of biotherapeutics and medical devices.
CE Mark Approval and First Implants of Boston Scientific’s Ingevity™ MRI Pacing Leads
Boston Scientific Corporation has announced CE Mark approval and European market launch of the INGEVITY™ family of magnetic resonance imaging (MRI) compatible pacing leads.
CE Mark for Boston Scientific’s REBEL™ Platinum Chromium Coronary Stent
Boston Scientific Corporation has received CE Mark approval for the REBEL™ Platinum Chromium Coronary Stent System, the company’s latest generation … continue reading “CE Mark for Boston Scientific’s REBEL™ Platinum Chromium Coronary Stent”
CE Mark for RTI Surgical’s Fortiva™ Porcine Dermis
Pretty much a year after having gained the FDA’s nod for its Fortiva Porcine Dermis Patch, RTI Surgical Inc. has received CE mark approval for the product and says it will begin distribution throughout Europe.
CE Mark for First 3D Stereoradiographic Planning Software
A pioneer in orthopaedic 2D/3D imaging, EOS imaging has announced the CE mark of hipEOS, a 3D hip arthroplasty planning software based on EOS biplanar 3D imaging.