Volcano Corporation a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, said today it has received clearance to market its new Visions® PV .035 Digital IVUS Catheter in both the US and Europe. The new intravascular ultrasound catheter is designed to image large vessels and facilitate the use of less iodinated contrast in endovascular procedures.
FDA
Covidien’s Nellcor™ Bedside Respiratory Patient Monitoring System Gains FDA And CE Mark
Covidien has announced U.S. FDA 510(k) clearance and CE Mark approval for its next generation of Nellcor™ Bedside Respiratory Patient Monitoring system.
FDA Gives Go-Ahead For Sunshine Heart C-Pulse ® Heart Assist System Study
Sunshine Heart Inc. has announced that it has received conditional approval from the FDA for an Investigational Device Exemption for its flagship C-Pulse extra-aortic, counter-pulsation, heart assist device.
Stryker Recall Of Neptune Rover Waste Management System
On June 5, 2012, Stryker initiated a Class 1 recall of the Neptune Waste Management System. Now that recall has been expanded to other iterations of the device because it appears they have been marketed without 510(k) clearance which FDA deems necessary in order to establish their safety and efficacy.
HyperBranch Completes Clinical Enrollment In FDA Dural Sealant Study
Hyperbranch possesses its own particular hydrogel which is already sold in Europe as a dural sealant for use following neurosurgery. Now the company has taken a step towards FDA approval with the news that it has completed enrollment in its pivotal IDE study.
Will EU Adopt FDA’s New Post Marketing Surveillance Approach?
No great surprises as FDA proposes four key areas in which it believes improvements will lead to more (and more meaningful) post-marketing surveillance feedback. It’s been issued for comment from stakeholders.
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.
500 Patient EndoBarrier® Pivotal Clinical Trial OK’d By FDA
GI Dynamics, Inc. has announced that it has received conditional approval from the U.S. FDA to commence what it’s calling a pivotal clinical trial of the EndoBarrier® for the treatment of patients who have uncontrolled type 2 diabetes and are obese.
InSightec Receives FDA Approval To Begin Phase I Parkinson’s Trial
InSightec Receives FDA Approval to Begin Phase I Parkinson’s Trial (via PR Newswire) TIRAT CARMEL, Israel, August 20, 2012 /PRNewswire/ … continue reading “InSightec Receives FDA Approval To Begin Phase I Parkinson’s Trial”
How Must It Feel To Have A Recalled Product Inside You?
FDA has issued updated guidance on the clinical management of problematic Riata and Riata ST ICD leads. We take a considered look at how patients must be feeling and how well they’re getting looked after through this whole stressful experience.
How Can Stryker’s Wingspan Neuro Stent Maintain Broad CE Mark In Europe When U.S Study Results Have Driven FDA To Restrict It’s Use?
The consequences of our distinct regulatory set-ups is that sometimes study information that drives indications for use one side of the pond is ignored on the other, despite the fact that it may have significant clinical consequences as seems to be the case with Stryker’s Wingspan Neurovascular Stent.
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 Class I Recall For Arrow International’s Multi-Lumen Venous Catheterisation Set with Blue FlexTip ARROWg+ard® Catheter
FDA has issued a Class I recall notice relating to Teleflex subsidiary Arrow International’s Multi-Lumen Venous Catheterisation Set, following the company’s May Field Corrective Action Letter.
Will FDA Panel Support First Retinal Prosthesis System?
Retinal prosthesis pioneer company Second Sight Medical Products Inc., has announced that a U.S. FDA Ophthalmic Devices Advisory Panel will take place on September 28th to review the company’s Humanitarian Device Exemption (HDE) market approval application for its Argus II Retinal Prosthesis System (Argus II prosthesis).