FDAnews Device Daily Bulletin
March 30, 2005 | Vol. 2 No. 63
Bacchus Vascular has announced the recent FDA clearance of the TRELLIS-8 Peripheral Infusion System, an advanced drug infusion catheter designed for the treatment of deep vein thrombosis and arterial occlusions by enabling targeted delivery of clot-dissolving drugs.
The FDA has conditionally approved an investigational device exemption for Archus Orthopedics' Total Facet Arthroplasty System (TFAS), allowing the company to initiate a pivotal clinical trial of the device in the U.S.
Power3 Medical Products has entered into a collaborative research agreement with New Horizons Diagnostics for the development of antibody-based diagnostic tests for neurodegenerative disease using the company's identified protein biomarkers.
CryoCath Technologies has received clearance from the FDA to initiate an investigational device exemption (IDE) study for the treatment of atrial fibrillation (AF).
Clarient and Applied Imaging announced that the two companies have reached a settlement ending the companies' patent infringement, unfair competition and misappropriation of trade secrets litigation.
Serologicals announced that Upstate Group, its wholly owned subsidiary, obtained the rights from the University of California to sell the anti-ZAP-70 monoclonal antibody for diagnostic use.
Tessera, a Seattle-based biomedical company, has released its first product, ProstaMark EPCA (Early Prostate Cancer Antigen), as an analyte specific reagent for commercial use in pathology laboratories to assist pathologists in their efforts to determine if cancer is present in the prostate.
Sigma Global, a direct-to-consumer marketer of pharmaceuticals and medical devices, announced it has acquired Global Health Services, a product development company currently focused on its SureOne diabetic insulin syringe product line, according to Chairman and CEO Bryan Chance.
Longport, a medical technology specialist in high resolution ultrasound imaging, announced they have been informed of $1.7 million NIH grant application for a three-year collaborative study of pressure ulcer development using the Longport EPISCAN I-200.
U.S. Genomics, a maker of single molecule biology tools for the life sciences industry, unveiled its Trilogy 2020 Single Molecule Analyzer.
Abbott and BioCurex announced they have entered into a licensing agreement for BioCurex's RECAF material and technology.
eGene announced that it has been issued U.S. Patent No. 6,870,167 "Multi-Color Multiplexed Analysis In a Bio-Separation System," by the U.S. Patent and Trademark Office.
EnteroMedics, a developer of medical devices for the treatment of obesity and gastrointestinal disorders, announced that the Mayo Foundation for Medical Education and Research, Rochester, Minn., has entered into an exclusive collaborative obesity device research and development agreement with the company.
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