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.
General 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.
Linx Laparoscopic Anti-Reflux Device Gains FDA Panel Support
Sphincter specialist Torax Medical Inc. has taken a significant step towards FDA approval for its Linx device, designed for treatment of Gastro-Oesophageal-Reflux Disease by gaining the unanimous support of FDA’s 9 member advisory panel.
Digital Agenda for Europe’s “Virtual Liver” Helps Detect Liver Tumours
Scientists and surgeons from France, Germany, United Kingdom and Switzerland have developed a “virtual liver”, using EU research funding, which will help surgeons better plan and carry out tumour operations and ensure quicker patient recovery.
CE Mark For Biomerix ASSURE Soft Tissue Repair Mesh
California-based Biomerix Corporation has announced that it has received CE Mark approval for its ASSURE soft tissue repair mesh.
EndoBarrier® Now Commercialised In Netherlands
GI Dynamics, Inc. is to transition its EndoBarrier® Gastrointestinal Liner from clinical research status to commercial availability in Netherlands.
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.
Angiodynamics Completes Enrollment In European Nanoknife Pancreatic Cancer Study
AngioDynamics has completed patient enrollment in its European prospective NanoKnife® System trial for the treatment of locally advanced unresectable pancreatic cancer.
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.
Technology Watch: Driveable Swimming Capsule Endoscope
Tel Aviv University researcher proposes MRI-controllable capsule endoscope to investigate digestive system
Counterfeit Medical Devices: More Probable Than Possible
RAM Medical has admitted to importing and selling counterfeit and contaminated surgical hernia mesh. Is this a one-off, or could such practices be widespread and global?
da Vinci Single Site Lap Chole System Gains FDA Approval
Intuitive Surgical, Inc. the global leader in minimally invasive robotic-assisted surgery, has announced that it has received FDA clearance to market its Single-Site Instrumentation for laparoscopic cholecystectomy procedures.
Two New Centres of Excellence in Germany for EndoBarrier®
US non-surgical obesity solutions company GI Dynamics, Inc. today announced that it has designated two new Centres of Excellence in Germany, bringing to three the number of specialist units offering the Endobarrier treatment in the country.
PleurX Peritoneal Catheter Drainage System Gets Provisional Nod From UK NICE
UK’s National Institute for Health and Clinical Excellence has found that use of PleurX’s peritoneal catheter drainage system is suported by evidence.