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.
Products
AANS Sees Zimmer Launch Puros® Matrix and BoneGraft Substitutes
Zimmer Spine, Inc., has announced the U.S. market launch of a comprehensive family of Puros Demineralized Bone Matrix (DBM) with Reverse Phase Medium (RPM) Putty, Putty with Chips, Gel and Paste, and Puros DBM Block and Strip products
Mynx Ace™ Vascular Closure Device Leaves No Implant Behind
AccessClosure Inc., has commercially launched its Mynx Ace Vascular Closure Device at ACC 2014. The company says the device is a safe and secure vascular closure product that provides consistent results with a new, easy-to-use deployment system to seal femoral artery access sites.
ACIST’s Rapid FFR System Launched at ACC 2014
Following FDA clearance in January, ACIST Medical Systems, Inc., has now announced the global introduction of the new ACIST|RXi™ Rapid Exchange FFR System – the world’s first Rapid Exchange FFR system. This device features new technology designed to provide physicians with a fast and easy way to perform Fractional Flow Reserve (FFR) procedures.
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.
New Surgiseal Twist™ Topical Skin Adhesive Breaks Cover at AORN 2014
Healthcare products company Medline is showcasing many products at AORN this weekend, but is using the event to launch Surgiseal Twist, a new delivery device for a cyanoacrylate topical skin adhesive.
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.
ScanMed Introduces New Orbit and Mandible Array to the MRI Market
MRI technology specialist, ScanMed of Resonance Innovations LLC, will be introducing its new Orbit and Mandible Array and Targeting System at this year’s AAPOS (American Association for Pediatric Ophthalmology and Strabismus) Annual Meeting in Palm Springs from April 2-6, 2014.
BD Launches New, Less Painful Diabetes Pen Needle in UK and Ireland
BD has unveiled its BD Micro-Fine Ultra™ with 5-bevel needle technology, which it is launching in the UK and Ireland. The company claims clinically demonstrated improved injection comfort for diabetes patients.
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.
Acumed’s Foray into Pelvic Trauma with Plating System
Better known for being a big player in extremities trauma, orthopaedic company Acumed says it is venturing into the new and expanding market of orthopaedic implants and instrumentation for the surgical repair of fractures and joint disruptions of the pelvis.
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.
Full Commercial Launch of Benvenue’s Kiva®VCF Treatment System for Spine Fractures
Benvenue Medical has chosen the Society for Interventional Radiology Annual Scientific Meeting at which to announce the full commercial launch of its system, supported by further favourable clinical data.
St. Jude’s New Optisure™ Defibrillation Lead Piggybacks Durata™ Success
St. Jude Medical, Inc. has announced the global launch of the Optisure™ Defibrillation Lead, joining the Optim™ lead family, which includes the company’s now famous Durata™ Defibrillation Lead.
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.