FDAnews Device Daily Bulletin
Feb. 18, 2005 | Vol. 2 No. 35
Conor Medsystems has announced six-month follow-up data that demonstrate favorable clinical results for the treatment of single or multiple de novo lesions in native coronary arteries.
FlowMedica's Benephit Infusion System, a new device designed to deliver medications and other therapeutic agents directly to the kidneys, has received CE Marking, enabling FlowMedica to make the Benephit system available to physicians in all member countries of the European Union.
Onset Medical has announced that the FDA has granted clearance to begin marketing the company's Pathway Ureteral Access Device in the U.S.
Integra LifeSciences has begun selling Newdeal foot and ankle products in the U.S. through its reconstructive surgery sales force.
Syneron Medical, a developer and marketer of ELOS combined-energy medical aesthetic devices, announced that it has filed a 510(k) application with the FDA for marketing clearance of its VelaSmooth system in the U.S.
Pall Corporation is introducing in Europe the Pall-Aquasafe AQF1C water filter, the latest addition to its line of point-of-use water filters for hospitals and other healthcare facilities.
Millenium Holding Group, a financial services holding company, announced that it has filed a complaint in District Court, Clark County, in the state of Nevada against Sutura, a medical device company based in Fountain Valley, Calif., and Fusion Capital Fund II and Fusion Capital Partners investment funds based in Chicago, with allegations of, among other things, Fusion's tortious interference with contract and Sutura's and Fusion's conspiracy to breach implied covenant of good faith and fair dealing.
Wright Medical Group has launched a reconstructive product, called Charlotte, for use in foot and ankle surgery.
Gen-Probe announced that the company has signed a supply and purchase agreement with F. Hoffmann-La Roche and its affiliate Roche Molecular Systems under which Gen-Probe will purchase products for use in molecular diagnostic assays for human papillomavirus (HPV).
Glucose monitoring device developer Glucon announced it was granted a U.S. patent for the use of photoacoustic waves originating in the blood vessel to calculate the concentration of glucose in the blood vessel.
SpectRx is partnering with Emory University as part of a grant to Emory from the Georgia Research Alliance to support FDA pivotal clinical trials for a new non-invasive cervical cancer detection device.
CPC of America announced that it has acquired a minority interest in Med Enclosure. CPC had formed Med Enclosure in 1999 as a vehicle for the development of a patented internal puncture closing device and technique known as "MedClose."
Advance Nanotech has announced a joint venture with Toumaz Technology Ltd. to bridge the gap between nanosystems and the macroscopic world.
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