Edwards’ critical care portfolio expands to Include non-Invasive platform with the acquisition of Dutch monitoring company BMEYE.
Technology
New Renal Denervation System Hits The Spot And Delivers Therapy Says Medtronic
Medtronic’s new design multi-electrode radiofrequency renal denervation system builds on experience with the Symplicity™ Renal Denervation System.
Deep Brain Stimulation Advances With EU Launch of Boston Sci’s Vercise™ DBS System
Boston Scientific Corporation has received CE Mark approval for use of its Vercise™ Deep Brain Stimulation System for the treatment of Parkinson’s disease. The company says this is the first and only commercially available DBS system to incorporate multiple independent current control, which is designed to selectively stimulate targeted areas in the brain.
CEO Change Signals Start Of InspireMD’s Embolic Protection Stent Commercialisation Plan
InspireMD, Inc. has announced that Ofir Paz, co-founder, board member and Chief Executive Officer of InspireMD since its founding in 2005, intends to step down as CEO as part of a planned transition to prepare the Company for formal commercialisation of its proprietary MGuard™ Embolic Protection Stent (EPS) platform technology for patients with Acute Myocardial Infarction.
Intelomed Receives FDA 510(k) Clearance For CVInsight Medical Device
Intelomed, Inc., has announced that it has received FDA 510(k) clearance for its CVInsight medical device which measures and displays vital information such as functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate of adult and pediatric patients.
BD’s New Needle Technology Eases Pain For Diabetics
BD Ultra-Fine™ Nano 4mm Pen Needles with PentaPoint™ Comfort are first to feature patented 5-bevel needle tip able to penetrate skin more easily for patients who require insulin injection
DiFUSION Technologies Announces Breakthrough Medical Polymer
DiFusion announced today the completion of a series of in vivo and in vitro clinical tests which, the company says, substantiate their claim that CleanFUZE resists surgical infection and promotes bone growth.
Did I get It All? Study Says Yes As MarginProbe® Accurately Identifies Cancer Tissue In Prostate Cancer Surgery
A new study demonstrates the potential for use of Dune Medical’s MarginProbe system in surgical margin assessment during radical prostatectomy procedures.
FDA Approves AF Ablation Device, But Not Yet For Use As An AF Ablation Device
Estech’s breakthrough technology for the first time combines the benefits of a bipolar clamp with the flexibility of an endoscopically guided probe with the capability of creating linear lesions anywhere on a beating heart. It’s for investigational use in AF ablation treatment in U.S right now.
Biodegradable Metal? But (Hopefully) Not Like My First Car
Combine the strength of steel with the absorption characteristics of a polymer like PLLA and you may have a new category of implant material. So hopes Bio DG which has just been granted a patent in the area.
FDA Approves Abiomed’s Higher Flow Impella®
Abiomed Receives FDA 510(k) Clearance for New, Higher Flow Impella Percutaneous Heart Pump, With Peak Flows of 4L/min
CE Mark For Neurosigma Means Fourth Quarter 2012 EU Launch Of Non-invasive Epilepsy And Depression Treatment
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).
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.
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.
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.