UK medical device company Surgical Innovations has gained FDA clearance for its Pretzelflex™ laparoscopic retractor.
Regulatory
CE Mark For Medtronic’s CD Horizon BalanC™Spinal System
Medtronic gains CE Mark approval for its CD HORIZON BalanC™ Spinal Fusion System, promising a new level of adaptablity to patient anatomy.
No Fear For Industry In Device Directives Revisions… Well, Not Yet
European Medical Device Regulatory changes: Eucomed’s John Brennan speaks at Medtec Europe Congress last week.
CE Mark for Spinal Motion’s Sub-5mm Kineflex®|C Cervical Total Disc Replacements
Cervical Disc Replacement specialist Spinal Motion has announced the CE marking of its sub 5mm Kineflex|C iterations.
Post-Operative Antiemetic Device Wins FDA 510(k) Clearance
FDA approval for non-invasive pressure device prevents Post-op nausea. Acupuncture without needles.
J&J Selling Vaginal Mesh Without FDA Clearance Might Make A Good Headline, But Doesn’t Change Much
Vaginal Mesh problems are going to land at someone’s door and J&J’s looking like a soft target. It transpires the company decided to launch “Prolift” in 2005 as an “insignificant change” to a previous device, so didn’t feel the need to tell FDA about it.
LIFT Luna Interbody Fusion Study Now Enrolling In Europe
Clinical trial of minimally invasive spinal fusion system now enrolling in Europe.
Is FDA About To Clip Stryker’s Wingspan?
Stryker’s Wingspan Stent is up for FDA panel review on March 23rd. FDA’s Executive Summary, released today doesn’t auger well as results of clinical study don’t seem to support safety and efficacy claims.
Cook’s Zilver® PTX™Peripheral Stent Gains Australian Approval
Vascular Surgeons in Australia now have access to a new technology, with the approval of Cook Medical’s Zilver PTX drug-eluting stent for treatment of peripheral artery disease.
Blue Medical Trumpets New Drug-Eluting Balloon/Stent Combination
Using a Drug-coated balloon to implant a bare metal stent might just be a smart idea, at least according to Dutch Cardiovascular specialists Blue Medical in announcing the launch of their innovative new offering.
CareFusion’s New Electrodiagnostic System Gains FDA Clearance
Carefusion’s Viking on Nicolet® EDX Electrodiagnostic system has gained FDA clearance and will be shown at forthcoming America Academy of Neurology meeting in New Orleans.
Medical Device Alert: Covidien LigaSure Dolphin Tip sealer/divider
Covidien in the news again, this time with UK recall of LigaSure Dolphin Tip Sealer for fear of loose pins in the handle.
Medical Device Alert: Medtronic EnTrust VR/DR/AT
UK’s MHRA issues a Medical Device Alert on Medtronic’s EnTrust ICD, which is at risk of losing charge.
Canada Approves Medtronic’s DBS For Epilepsy And Boston’s Cardiac Ablation System
Two new device approvals announced for Canada this week. Neither Medtronic’s DBS therapies for epilepsy nor Boston Scientific’s RF ablation catheter are US FDA approved, but Health Canada are clearly convinced by the weight of the submissions.
Everflex: FDA Releases Summary Documents
FDA has now released summary information relating to last week’s newly US-cleared Everflex peripheral vascular stent from Covidien.
MHRA Comes Out Fighting
Dost thou think the agency protests too much? MHRA adopts a defensive stance against sniping media.