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.
FDA Approval
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.
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.
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.
FDA And CE Approval For Medtronic’s New Cryoballoon Means Improved Pulmonary Vein Isolation
Medtronic’s Arctic Front Advance™ Cryoablation System now delivers cold therapy to a larger area more evenly, the company claiming that this will aid cardiologists in delivering cardiac ablation therapy.
Covalon Announces FDA Clearance For SurgiClear™ Antimicrobial Silicone Wound Dressing
Covalon Announces FDA Clearance for SurgiClear™ Antimicrobial Silicone Wound Dressing (via PR Newswire) MISSISSAUGA, ON, Aug. 21, 2012 /PRNewswire/ – … continue reading “Covalon Announces FDA Clearance For SurgiClear™ Antimicrobial Silicone Wound Dressing”
FDA Approves Sanofi’s Auvi-Q™ Voice-guided Epinephrine Auto-injector
Sanofi’s breakthrough device talks anaphylaxis patients and caregivers through the injection process at what is likely to be a particularly stressful time.
510(k) Clearance For Stryker’s Trevo® Pro Clot Retrieval System
Stryker Neurovascular’s Trevo® Pro Retriever has gained FDA 510(k) market clearance. The Trevo® Pro Retriever outperformed Stryker’s own Merci® Retriever in a clinical study first published in May, showing improved revascularisation compared with the older generation product.
New Bone Marrow Aspiration Catheter Gains FDA Clearance
Florida based autologous solutions company Biologic Therapies has gained FDA clearance for its Bio-MAC™ Bone Marrow Aspiration Catheter which it claims will enhance physicians’ use of autologous Bone Marrow Aspirate Concentrate in surgical procedures for the treatment of orthopedic conditions.
510(k) For Ethicon Endo’s New HARMONIC ACE®+ Shears With Adaptive Tissue Technology
Ethicon Endo-Surgery, Inc. has announced U.S. FDA 510(k) clearance of its HARMONIC ACE®+ Shears with Adaptive Tissue Technology. The company says this represents the next generation in its “best-in-class” HARMONIC® portfolio of ultrasonic surgical devices that can handle multiple surgical jobs.
FDA PMA Approval For Codman’s MEDSTREAM™ Programmable Baclofen Infusion System For Spasticity Therapy
Codman has announced receipt of U.S FDA approval through a PMA supplement for its MEDSTREAM™ Programmable Infusion System. MEDSTREAM is an implantable infusion pump and catheter system used in the treatment of spasticity, a movement disorder often caused by stroke, cerebral palsy, multiple sclerosis or spinal cord injury.
FDA Approves Abbott’s Omnilink Elite® Vascular Balloon-Expandable Stent System For Treatment Of Iliac Artery Disease
Abbott has announced U.S FDA approval for its Omnilink Elite® Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease. The stent, already CE marked and marketed in Europe, has passed muster with the FDA following a comparative multicentre clinical study which suggested it outperforms endpoints established from previous stent studies..
510(k) For VICTUS™ Femtosecond Laser Platform
Eye health company Bausch + Lomb, and Technolas ™ Perfect Vision GmbH , a leading ophthalmology laser company, have jointly announced that the VICTUS™ Femtosecond Laser Platform has received FDA 510(k) clearance. The VICTUS platform is the first femtosecond laser capable of supporting cataract and corneal procedures on a single platform.
510(k) Clearance For NeuroMetrix SENSUS™ Pain Management Device
NeuroMetrix, Inc., a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, announced that it has received 510(k) clearance for its SENSUS™ Pain Management device from the U.S FDA.
FDA Clears DePuy Synthes Spine’s Expedium® And Viper® Systems For Adolescent Idiopathic Scoliosis
DePuy Synthes Spine has received FDA 510(k) clearance for use of its EXPEDIUM®(pictured), VIPER®, and VIPER®2 Spine Systems on patients with adolescent idiopathic scoliosis (AIS), expanding the scoliosis indication for the pedicle screw systems, previously only approved in adults.