FDAnews Device Daily Bulletin
March 25, 2005 | Vol. 2 No. 60
The FDA has approved the GORE TAG Endoprosthesis System, an endovascular grafting system that is intended to prevent ruptures of descending thoracic aneurysms by making a new path for blood flow.
Medtronic has announced the recent introduction of the Medtronic Attain Select 6238 TEL Guide Catheter Set that aids in the safe and effective implantation of device leads in the veins that serve the left side of the heart for the treatment of heart failure.
The FDA has given Conor Medsystems conditional approval of an investigational device exemption to begin its COSTAR II pivotal clinical trial to support U.S. regulatory approval of the company's CoStar stent.
The first patient was treated at Stanford University Medical Center in a clinical trial evaluating a drug-coated stent from Cook for peripheral arterial disease (PAD), a serious medical condition that affects more than 10 million Americans each year.
MIV Therapeutics (MIVT) announced that its wholly owned subsidiary, MIVI Technologies -- which is involved in the research and development of multilayer coating technologies with drug eluting capability for cardiovascular stents and other implantable devices -- has received a government grant for the research program titled, "Development of Novel Drug Eluting Composite Coatings for Cardiovascular Stents."
STERIS announced that it has completed the acquisition of FH Surgical SAS, a privately held manufacturer of surgical tables with approximately 40 employees and manufacturing facilities in Orleans, France.
HemoSense announced the signing of distribution agreements with FDI Medical, STAT Technologies and Whitmire Medical to market, sell and distribute HemoSense's INRatio product line to professional healthcare providers in the U.S.
Masimo, the inventor of read--through motion and low perfusion pulse oximetry, announced that a federal court jury in Los Angeles has found that Tyco Healthcare violated the antitrust laws through anticompetitive business practices specifically related to the sale of its Nellcor pulse oximetry products.
Cygnus announced that it completed the sale of substantially all of its assets (other than cash and cash equivalents, accounts receivable and its rights in the arbitration matter with Ortho-McNeil Pharmaceutical) to Animas and Animas Technologies for $10 million in cash.
Siemens Medical Solutions announced that its 550 TxT Treatment Table has received 510(k) clearance from the FDA and is now commercially available in the U.S.
Atlantis Components announced that the Atlantis Abutment is compatible with the Straumann RN Implant.
Nymox Pharmaceutical continues to make progress in the global marketing strategy for the company's urine testing technology for Alzheimer's disease.
Health Canada -- the Canadian federal health department -- announced that Elekta Neuromag is cleared for sale within the Canadian healthcare system.
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