Meeting Announcement: July 24-25, 2013 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory CommitteeApril 25, 2013 12:00 am | by U.S. Food & Drug Administration | Comments
On July 24, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device.
510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device, May 17, 2013April 25, 2013 12:00 am | by U.S. Food & Drug Administration | Comments
The purpose of the meeting is to discuss FDA’s past, present, and future policy on 510(k) Modifications with external stakeholders. FDA seeks comment from stakeholders on different options, both in the form of submissions to the docket for the Federal Register notice associated with this meeting and in discussion during the public meeting.
Humans are veritable chemical factories - we manufacture thousands of substances and transport them, via our blood, throughout our bodies. Some of these substances can be used as indicators of our health status. A team of EPFL scientists has developed a tiny device that can analyze the concentration of these substances in the blood.
Ergoresearch Ltd. and Victhom Human Bionics Inc. announced today that the Superior Court of Québec has issued a final order approving the previously-announced plan of arrangement relating to the acquisition by Ergoresearch Inc., a direct wholly-owned subsidiary of Ergoresearch, of Victhom.
Eastman Chemical Company has announced it will expand its non-phthalate plasticizer portfolio with the addition of Eastman 168™ SG (sensitive grade) non-phthalate plasticizer. Eastman 168 SG non-phthalate plasticizer is an enhanced grade of the Eastman 168 non-phthalate plasticizer.
Medstrat, Inc., a leading provider of picture archiving and communications system (PACS) technology to Orthopaedic practices and hospital systems, announced today that it has posted the terms of the Settlement Agreement by which Merge Healthcare dismissed its November 14, 2012 lawsuit filed against Medstrat.
Potential for Delivery System Catheter Separation Prompts Cook Medical To Initiate Voluntary Global Recall of Zilver® PTX® Drug Eluting StentApril 24, 2013 4:40 pm | by The Associated Press | Comments
Based on its investigation into a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a nationwide/global voluntary recall of its Zilver® PTX® Drug Eluting Peripheral Stent.
Life Care Medical Devices Ltd Announces CE Mark And Planned Commercialization For Laparoscopic Surgery Access DeviceApril 24, 2013 4:29 pm | by The Associated Press | Comments
Life Care Medical Devices Ltd today announced the issuance in August 2012 of CE mark for its Keyhole Cup Laparoscopic Access Device. Keyhole Cup addresses a critical need in the laparoscopic surgery market and was developed to advance the standard of care for laparoscopic access.
Minnesota medical device maker Vascular Solutions (NSDQ:VASC) wasn't able to dodge a federal off-label marketing lawsuit over its Vari-Lase varicose vein treatment devices, the company revealed in its latest financial report. A Texas court ruled last month against Vascular Solutions' motion to dismiss a U.S. Attorney's Office complaint...
Officials have announced a new $3.4 million bioscience research facility at the University of Illinois at Chicago. The 12,000-square-foot facility is being built with state capital funds and money from UIC. Gov. Pat Quinn and UIC officials announced the facility on Wednesday at the proposed site.
The FDA laid out plans to revamp its postmarket surveillance of medical devices, and a large part of that has to do with finalizing and implementing a long-awaited Unique Device Identifier program to better track and monitor devices. The federal watchdog agency aims this year to finalize a UDI rule...
It's unlikely that his waning days as chairman of the Senate Finance Committee will see Sen. Max Baucus (D-Mont.) having a "Come-to-Jesus" moment on the medical device tax, but his retirement does change the game on repealing the levy.
Colorado-based medical device maker Spectranetics (NSDQ:SPNC) broke out the red ink in 2013, blaming the swing partly on the newly implemented medtech excise tax, which requires that companies pay a 2.3% levy on all U.S. sales of applicable medical devices.
WALTHAM, Mass.--(BUSINESS WIRE)--Apr 24, 2013--NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the treatment of diabetic peripheral neuropathy (DPN), announced that it had entered into an agreement with Omron Healthcare Co., Ltd. to be the exclusive distributor for NC-stat ®...
Texas Institute for Robotic Surgery Among First in Nation To Perform Single-Site Robotic Hysterectomy SurgeryApril 24, 2013 10:53 am | by PR Newswire | Comments
AUSTIN, Texas, April 24, 2013 /PRNewswire/ -- The Texas Institute for Robotic Surgery at St. David's North Austin Medical Center recently became one of the first facilities in the nation to perform a hysterectomy using a new single-site platform for robotic surgery.