FDAnews Device Daily Bulletin
Jan. 24, 2005 | Vol. 2 No. 16
Sorin, a European medical technology company specializing in the treatment of cardiovascular diseases, has completed enrollment of its JUPITER II clinical trial.
Terumo Cardiovascular Systems introduced the VirtuoSaph Endoscopic Vein Harvesting (EVH) System for use in coronary artery bypass grafting.
CalbaTech, a life sciences company concentrating on providing products and platforms to the research market for biotech and pharmaceutical companies and to academic institutions, announced that its wholly owned subsidiary, LifeStem, launched a major project to develop its Stem Cell Delivery Device.
Gen-Probe has announced that bioMerieux has exercised an option to develop diagnostic products for certain undisclosed disease targets using Gen-Probe's patented ribosomal RNA technologies, pursuant to terms of an agreement first disclosed Oct. 6, 2004.
Third Wave Technologies has achieved ISO 13485:2003 certification, a stringent, globally recognized standard of quality management for medical device manufacturers.
HealtheTech, which develops and markets handheld medical devices that measure software metabolism and nutrition, filed with the SEC to deregister its common stock under the Securities Exchange Act of 1934.
DOBI Medical has sold 12 ComfortScan systems in Europe and Asia for 2004.
A technique called molecular breast imaging (MBI) is highly sensitive in detecting small lesions and can also spot tumors missed by mammography and ultrasound, researchers report.
Edwards Lifesciences has announced the U.S. launch of its ThermaFix advanced tissue treatment process, which will now be available on the company's Carpentier-Edwards PERIMOUNT Magna replacement tissue heart valves.
Physicians from the University at Buffalo and Dent Neurologic Institute has unveiled one of the first combined PET-CT scanners to begin operation in the Buffalo area.
PRODUCTS AND APPLICATIONS PROLIFERATE IN THE GROWING MARKET FOR SURGICAL SEALANTS, GLUES AND WOUND CLOSURE
The market potential for products in the surgical securement field is driven by a combination of new technologies coming to market and expanding application caseloads.
Endologix has announced that a clinical paper presented at the International Symposium for Endovascular Therapy (ISET) suggests that three years following treatment with the company's Powerlink System, patients (from the pivotal PMA study) experienced decreases in aneurysm sac diameter and volume, and less angulation of the aorta.
Invacare has entered into a new revolving credit facility for a five-year term.
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