Initial results of ReCor’s REDUCE First-In-Man clinical study presented at “TRenD 2012” transcatheter renal denervation scientific meeting as company gains CE mark for its PARADISE™ system.
Regulatory
FDA Slow To Clear Products When EU Data Lacking
New paper compares CE vs FDA and concludes both need a makeover.
FDA Clears Resolute Integrity™ DES For Coronary Artery Disease Including Diabetes Indication
Medtronic Inc’s Resolute Integrity™ Drug-Eluting Stent for treating coronary artery disease has been approved by the FDA, after studies showed consistent clinical performance among a wide range of patients, including individuals with diabetes.
J&J Responds To New York Times
Johnson & Johnson DePuy sees fit to respond to New York Times article it claims to contain untruths regarding how it behaved during the all-metal implant situation.
FDA Clears Two New Clavicle Repair Technologies
Suspension Orthopaedics has gained FDA clearance for some interesting clavicle plates addressing specific problems associated with clavicular fracture.
CE Mark For Edwards INTUITY Valve: Rapid Deployment Through Small Incision
Edwards Lifesciences Corporation, today announced that it has received CE Mark in Europe for its INTUITY Aortic Valve System.
St Jude Refutes NEJM Claims About Its PMS Procedures And Durata.
St Jude Medical’s fighting talk in response to NEJM editorial suggesting its surveillance procedures are lacking and that Durata may suffer the same fate as its older brothers.
Metal-on-Metal: Should FDA Concerns Have Made DePuy Act Sooner Overseas?
A new article in the New York times suggests J&J DePuy were wrong in continuing to sell product overseas after FDA raised concerns. If that happened every time FDA demanded more clinicals we might as well harmonise.
Custom Spine’s Portfolio CE Marked
Custom Spine Inc has gained CE mark approval for all its products.
No Long Guidewire, Less Bruising: FDA Clearance for AngioDynamics NeverTouch Direct™Procedure Kit For Use With the VenaCure EVLT® System
NeverTouch Direct Kit for treatment of Varicose Veins With Fewer Procedure Steps, has gained FDA clearance.
Buying Single-Use Pressure Transducer Could Save Money
This simple in-line transducer could have many applications including diagnosis of compartment syndrome, one of the most costly hazards in Orthopaedics.
Stryker’s Wingspan: A Regulatory Conundrum For FDA?
In short Stryker’s brain stent has been used in USA since 2005 on a Humanitarian Device Exemption (HDE) basis and … continue reading “Stryker’s Wingspan: A Regulatory Conundrum For FDA?”
New Research Suggests Sprint Fidelis Guidance Should Be Reviewed
Higher failure rates identified by researchers may indicate a policy of replacing Sprint Fidelis ICD units that haven’t malfunctioned.
Health Commission Urges Tighter EU Regulatory Controls Following PIP
Should European Union member states take immediate steps to tighten regulatory controls over medical devices and technologies in the wake of the PIP scandal?
Implantable, Programmable Drug Pump Gains FDA Clearance
The Prometra implantable, programmable pump from Medasys, represents the first non-peristaltic drug-infusion device to gain PMA approval. The product is already CE marked and available in selected European countries, with full EU roll-out expected in the next few months.
CE Mark For Implantable Hemodialysis Access Device From Vital Access
Vital Access has its press release nicely in place, but we’d like to know how to contact the company let alone how to buy its new implantable hemodialysis access device.