FDAnews Device Daily Bulletin
April 11, 2005 | Vol. 2 No. 71
St. Jude Medical announced it has completed the acquisition of the business of Velocimed, a privately owned company that develops, manufactures and markets specialty interventional cardiology devices.
A federal appeals court rejected a claim by two lawyers who argued that the federal Medicare program was defrauded by a company that made defective wires for heart pacemakers.
Boston Scientific announced that it has received CE Mark for three large vessel sizes (4.0 mm, 4.5 mm and 5.0 mm) of its Taxus Express2 paclitaxel-eluting coronary stent system in Europe and other international markets.
Novare Surgical Systems announced that it has received clearance from the FDA to market its family of EndoLink surgical instruments, single-use hand-held instruments that incorporate six degrees of articulating freedom.
Bio-Rad said it has made an $82 million unsolicited offer to buy BioSource International.
Utah Medical Products continues its efforts to discover the basis for a lawsuit filed eight months ago by the FDA in the U.S. District Court in Salt Lake City, alleging failure to comply with the FDA Quality System Regulation (QSR).
MIV Therapeutics, a developer of next-generation biocompatible coatings and drug delivery technologies, has filed two new patent applications that will enable the development and manufacture of an advanced new class of drug-eluting coatings capable of delivering multiple medicines from a cardiovascular stent or other implanted medical devices.
Biophan Technologies has announced the development of a new, ultra-small model of the implantable and wearable, highly precise ceramic SQUIGGLE motor that's half the size of previous models, with significant improvements in precision and electrical efficiency compared to electromagnetic motors.
CardioTech International announced that it has submitted to its European Notified Body an application to obtain CE Marking approval of its CardioPass Artificial Coronary Artery Graft.
Varian has introduced a revolutionary, new design for nuclear magnetic resonance probes used to determine the molecular structures of proteins and other biomolecules in the solid state.
XDx, a molecular diagnostics company, announced the launch of an innovative test for the management of heart transplant patients.
Richard Walmsley, Chief Executive Officer of Norwood Devices, a division of medical technologies group Norwood Abbey, announced the company had received Therapeutic Goods Administration (TGA) approval for its Centurion SES Epikeratome the key component of Epi-LASIK technology, the next generation of vision correction surgery.
Sonic Innovations, a producer of advanced digital hearing aids, announced the release of its Innova product family.
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