FDAnews Device Daily Bulletin
March 31, 2005 | Vol. 2 No. 64
Boston Scientific has announced the nationwide release of the Precision Spinal Cord Stimulation (SCS) System to treat chronic, debilitating pain.
Zimmer Holdings has acquired worldwide distribution rights to a Universal Locking Plate technology for trauma fixation systems that is designed to improve treatment of high-energy fractures and fractures in osteoporotic patients.
A California arbitrator ordered Medtronic, a maker of pacemakers and other medical devices, to pay $50.2 million plus interest to privately held Etex for breaching a contract, Medtronic said.
AngioDynamics has announced the release of the Total Abscession general drainage catheter, a catheter designed to percutaneously drain abscesses and other fluid collections.
BSP Biological Signal Processing announced that it has received FDA approval for the marketing and sale of its HyperQ System.
Bio-Matrix Scientific Group announced that it is evaluating its CAD/CAM designs for stem cell and tissue management instrumentation.
Encore Medical LP is introducing a new total shoulder prosthesis after getting premarket clearance from the FDA.
MedMira, developer of rapid flow-through diagnostic technology, announced that it has successfully upgraded its quality management system to the ISO 13485:2003 standard; the highest standard of quality in medical device manufacturing.
OccuLogix announced that, in connection with entering into a supply and co-marketing agreement with Rheogenx Biosciences, OccuLogix has re-acquired its patent, know-how and trademark rights to nonophthalmic indications for RHEO in North America that the company had previously licensed to Rheogenx.
Jarvik Heart, a developer of advanced technology for the treatment of heart failure, announced that it has received conditional approval to begin a pivotal trial of the Jarvik 2000 FlowMaker for bridge-to-transplant use.
ACI Medical announced positive results from a new, independent study that found its ArtAssist medical device to be an effective method for improving the long-term walking capacity and quality of life for patients with walking impairment due to arterial disease.
Physicists at the California Institute of Technology have created the first nanodevices capable of weighing individual biological molecules.
Siemens Hearing Instruments is presenting Acuris, an advanced digital hearing system, to audiologists for the first time at the American Academy of Audiology convention on March 31-April 2.
The FDA has determined that ultrasonic scalpels reprocessed by Vanguard Medical Concepts Inc. are "substantially equivalent" to new and has cleared the company to resume sales of the product.
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