A US consumer protection website is urging regulators to move more quickly and decisively in dealing with the thorny subject of transvaginally inserted organ prolapse meshes.
Gynaecology/Obstetrics
Pretzelflex™ Laparoscopic Retractor Gains FDA Clearance
UK medical device company Surgical Innovations has gained FDA clearance for its Pretzelflex™ laparoscopic retractor.
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.
Cryolife Breaks Quarterly Financials Record
Despite losing Hemostase revenue, Cryolife has reported record Q4 and significant annual revenue growth, giving it optimistic outlook for the near term as it enacts global strategic initiatives.
Baxter Completes Acquisition Of Synovis
Baxter’s previously advertised agreement to buy Synovis has now been consummated with the approval of Synovis’ shareholders.
Cervical Ripening Balloon from Cook Medical Now Available with Stylet
Cook’s new ripening balloon features a stylet to ensure easy and accurate balloon positioning.
510(k) For Bovie’s Patented J-Plasma™ Technology
Bovie Medical Corporation, has announced that it has received 510k clearance from the Food and Drug Administration (FDA) to market its J-Plasma™ handpiece with retractable cutting feature for soft tissue coagulation during surgery.
Robot Surgery Questioned: Will This Slow Adoption?
Robot Surgery questioned on patient benefit and economics in USA study.
Cardica Stapler Problems In Thicker Tissue: EU Clinical Trial Suspended
Californian Stapler Company Cardica has suspended enrollment in its European clinical trial of the MicroCutter XPRESS 30 due to a small subset of deployments where the XPRESS 30 did not perform satisfactorily in thicker tissue.
FDA Clearance For da Vinci Vessel Sealer: CE Mark Next?
Intuitive Surgical, Inc. has announced that it received FDA clearance to market its EndoWrist® One™ Vessel Sealer instrument for use with the da Vinci® Si™ Surgical System.
Uro/Gyne Surgical Mesh Implants: FDA Updates Position
FDA has announced a heightened degree of scrutiny regarding transvaginally inserted meshes and is considering reclassifying from Class II to Class III.
CE Mark For Airstrip Mobile Patient Monitoring Applications
Texas based AirStrip Technologies, Inc. has received CE Mark certification to market its innovative mobile patient monitoring applications in the European Community as well as other international territories outside Europe.
CE Mark For Robotic Catheter Guidance Control and Imaging™System .
California-based Magnetecs Corporation has reported that the company’s Robotic Catheter Guidance Control and Imaging™ (CGCI) System has received CE Marking certification.
Carl Zeiss Meditec Closes Financial Year on a High and Pursues Growth Course
Carl Zeiss Meditec bucks the trend with growth in all business areas and increased profitability.
Report Suggests Orthopods Like Ortho Companies, While Cardiologists Don’t Like Cardiology Companies
Details of how differing specialties make Medical Device purchase decisions have been quantified in Millennium Research Group’s new Perception Pulse Report
Non-Invasive Uterine Fibroid Ablation Gets UK NICE Nod
The UK’s National Health Service has issued guidelines for the company’s ExAblate focused ultrasound device for the removal of uterine fibroids.