NeuroSigma, Inc., a Los Angeles-based medical device company, announced today that it received CE Certification for its external Trigeminal Nerve Stimulation (eTNS™) system, called the Monarch™, for the adjunctive treatment of epilepsy and major depressive disorder, for adults and children 9 years and older. NeuroSigma’s approval was supported by years of safety and compelling efficacy data generated in clinical trials conducted at the University of California, Los Angeles (UCLA) and the University of Southern California (USC).
Regulatory
CE Mark For World’s Smallest Surgically Implanted Blood Pump
US/German device company CircuLite®, Inc. has announced that it has received CE Marking approval for the Synergy® Circulatory Support System, claimed by the company to be the world’s smallest surgically implanted blood pump designed for long-term use in patients diagnosed with the condition.
LDR Says Its Newly FDA Cleared Avenue® L Lateral Lumbar Cage System Represents The Pinnacle Of Lumbar Fusion
Spinal implant company LDR has announced FDA 510(k) clearance for its Avenue L Lumbar cage system which it says is the first lateral zero-profile lumbar cage with integrated in-line plating featuring self-guided VerteBRIDGE® plating technology.
CE Mark For RAPDx® Pupillograph Device Brings New Level Of Diagnostic Test
Konan Medical USA, Inc. has announced that its RAPDx® pupillograph for screening of defects in pupil function has received the European CE Mark. The company says its device breaks new ground, representing a diagnostic step change from the old “swinging flashlight” test.
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.
Respironics Recalls V60 Ventilators Over Motor Failure Concerns
Respironics California, Inc., a division of Philips Healthcare has completed notifying its U.S customers of a voluntary recall of 116 Respironics V60 Ventilators in the country and has confirmed that 33 have already been updated.
FDA OK’s U.S. Trial of Pulmonx Emphysema Therapy
Interventional Pulmonology company Pulmonx, has announced that the U.S. FDA has approved its request for an Investigational Device Exemption (IDE) to commence a multi-centre pivotal clinical trial which the company hopes will support a subsequent premarket approval application (PMA) for the Zephyr® Endobronchial Valve (EBV).
CoreValve®: High Risk Patient Study Enrollment Complete, FDA Says Yes To Start Intermediate Risk Patient Study
Medtronic, Inc. is announcing twin milestones for its CoreValve® clinical program on the long road to U.S. approval. First, it completed enrollment in its study of high risk patients in its U.S. Pivotal Trial, and then FDA gave it the nod to start a global trial in intermediate patients.
FDA Clears Toshiba’s Aquilion™ RXL CT System: New Technology Means Radiation Dose Reduction For Clinicians And Patients
Toshiba America Medical Systems, Inc. has received FDA clearance for its Aquilion™ RXL Edition CT system. The Aquilion RXL reconstructs images faster and includes the latest dose reduction technologies, providing what Toshiba says is faster, safer information to physicians and patients.
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.
CE Mark And First Clinical Use For Acandis® Acclino® 1.9F Neuro Stent System
German Neurovascular device company Acandis, has announced the CE mark approval of its novel Acclino® 1.9F low profile stent system, designed for use in the interventional neurovascular field as an adjunctive product in treating intracranial aneurysms with coils.
Two CE “Thumbs Up” For Boston Scientific’s Precision™ Plus Spinal Cord Stimulator
Boston Scientific’s Precisiopn Plus Spinal Cord Stimulator is now CE marked for peripheral nerve stimulation and implantees can receive MRI head-only scans, opening up diagnostic options for clinicians in Europe.
Bold Claims For CarpalFiX™ Hand & Wrist Fusion System As It Gains FDA Clearance
Extremity Medical LLC claims its device delivers superior compression and stable fixation for fusion while remaining zero profile and avoiding damage to vital articular surfaces. The system has just gained FDA clearance.
CE Mark For Elixir’s Biodegradable Polymer Coating/ Drug Elution Combo Stent
Elixir Medical claims to be the first company to now offer both durable and biodegradable polymer platforms for DES with the news that its absorbable polymer/drug eluting technology has been CE marked in the form of its DESyne BD Novolimus eluting stent system.
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.
NICE Asks The Audience On Exogen
Smith & Nephew has announced that the UK’s National Institute for Health and Clinical Excellence (NICE) has issued draft guidance supporting the case for utilising the Exogen Ultrasound Bone Healing System. It’s now putting its draft findings out for consultation.