FDAnews Device Daily Bulletin
March 10, 2005 | Vol. 2 No. 49
Conor Medsystems presented 12-month follow-up data from its PISCES (Paclitaxel In-Stent Controlled Elution Study) clinical trial at the American College of Cardiology scientific session in Orlando, Fla., that supported the long-term safety and efficacy of Conor's novel cardiovascular stent technology.
Siemens has received 510(k) clearance from the FDA to market the new ACUSON AcuNav 8F ultrasound catheter.
Sutura has announced the completion of a successful audit leading to a number of certifications for the manufacture of the company's SuperStitch closure product line.
Rapid dermal anesthesia was achieved in a study using Sontra Medical's SonoPrep ultrasonic skin permeation followed by two minutes of active drug transport with iontophoresis, a needle-free method of delivering drugs through the skin using low-level electrical current, the company said.
Novadaq Technologies announced that Nimesh Desai and Stephen Fremes reported data on a 120-patient prospective study conducted at Sunnybrook and Women's College Health Sciences Centre in Toronto, Canada, using Novadaq's proprietary Spy Intra-operative Imaging System for the assessment of graft quality during Coronary Artery Bypass Surgery (CABG).
Syneron Medical has priced the offering of 7 million of its ordinary shares being sold by selling shareholders at $28 per share.
Ambion Diagnostics, a division of Ambion, has entered into a new agreement with Wyeth Pharmaceuticals to continue its alliance in the development and supply of cGMP-grade RNA that will be incorporated as a component in Wyeth's innovative vaccine program.
Biomet announced that the FDA has granted marketing clearance for its patented ArComXL Highly Crosslinked Polyethylene, an engineered polymer that has demonstrated a 47 percent to 64 percent volumetric wear rate reduction over Biomet's own ArCom Polyethylene.
Innocoll announced that its wholly owned subsidiary, Syntacoll AG, has been granted two important patents.
IVMD announced the results of recent clinical trials conducted in connection with its labor prediction device.
EP MedSystems, a maker of electrophysiology products used in cardiac rhythm management, began shipping certain EP catheters to its customers from its offshore manufacturing efforts in Mexico.
ZymeQuest, a company that discovers, develops and commercializes carbohydrate-modified blood products for use in transfusion medicine, has exercised its option to license worldwide rights to a new method of treating platelets developed by Brigham and Women's Hospital.
Fresh off a U.S. Patent and Trademark Office ruling that overturned a patent related to the collection and preservation of stem cells, ThermoGenesis - which makes equipment used to store such cells -- has asked the government to consider rejecting the claims made in two more.
Cholestech announced the introduction of the Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) test at the 54th Annual Scientific Session of the American College of Cardiology.
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