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”
Approval/Clearance
Medtronic’s Newly CE Marked Cardiac Resynchronisation Therapy Devices Preserve Normal Heart Rhythm
Medtronic has announced CE mark approval for two new CRT devices which automatically adapt to patients’ electrical rhythms, improving response to life-saving therapy.
CE Mark And EU Launch For Abbott’s XIENCE Xpedition™ “Extraordinarily Deliverable” Drug Stent
Abbott has announced that the XIENCE Xpedition™ Everolimus Eluting Coronary Stent System has gained CE Mark approval for the treatment of coronary artery disease. The company is launching the product immediately in CE Mark countries.
Attrius® Cardiac PET System Gains CE Mark
Based out of Shenyang, China, Neusoft Positron Medical Systems, a joint venture between Neusoft Medical Systems Co., Ltd., and Positron Corporation has received ISO certification (9001:2008 & 13485:2003) and CE Mark approval for the Attrius® PET Systems.
CE Mark Means EndoStim LES Stimulator Is Now A treatment Option In Gastro-esophageal Reflux Disease
EndoStim B.V. has announced CE Mark approval of its LES Stimulation System for the treatment of gastro-esophageal reflux disease (GERD). The system uses low energy electrical pulses to strengthen a weak or dysfunctional lower esophageal sphincter muscle.
CE Mark for Gore’s Hybrid Vascular Graft Signals Preservation Of Dialysis Access Sites
W L Gore’s Hybrod Vascular Graft was FDA cleared two years ago, and now the company has announced it has its CE Mark, which it expects will bring a new level of utility to Vascular Surgeons in Europe.
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.
Sunshine Getting Investors’ Hearts Racing
Sunshine Heart tells us it’s come up with a device upgrade which will make its CPulse heart assist device run quieter and less bulky. The company awaits the FDA’s formal confirmation that it’s good to go, but the conditional approval has been announced. And the share price has gone up.
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.