FDAnews Device Daily Bulletin
Feb. 17, 2005 | Vol. 2 No. 34
Guidant has initiated a recall of its Voyager Coronary Dilatation Catheters sized 1.5 mm to 3.5 mm because of potential leaks.
Alimera Sciences, an ophthalmic pharmaceutical company, and Control Delivery Systems (CDS), a maker of innovative drug delivery systems for the eye, announced a worldwide agreement to co-develop and market a new pharmacologic treatment indicated for diabetic macular edema (DME), a major cause of vision loss in people suffering from diabetic retinopathy.
Baxter Healthcare has received 510(k) clearance from the FDA to market a wireless pump connectivity interface that enables hospitals to connect Baxter's Colleague CX infusion pump to its Patient Care System.
Diagnostics manufacturer Inverness Medical Innovations has signed a deal to purchase devicemaker Ischemia Technologies for approximately $22.4 million in stock.
Regeneration Technologies (RTI), the Florida-based processor of orthopedic, cardiovascular and other allograft implants, announced that the company's bone paste product has received 510(k) clearance from the FDA.
Biopotential Capital, a capital pool company listed on the TSX Venture Exchange, announced that it has signed the share exchange agreement with Osta Biopharma, a Montreal-based private company specializing in developing novel diagnostics and therapeutics for osteoporosis and osteoarthritis.
NIR Diagnostics, a developer of near-infrared handheld reagentless medical instruments, announced that, further to the tax assisted financing announced on Dec. 31, 2004, the company has exercised its rights to reacquire 100 percent interest in the GlucoNIR business.
Calypte Biomedical said that it has started trials of its Aware rapid HIV-1/2 test in Africa. The trials will evaluate the test using blood, saliva and urine as specimens.
Medical technology company Conmed said its board authorized the repurchase of up to $50 million of the company's common shares from time to time in the open market or in private transactions.
A urine test that detects proteins given off by malignant growths can identify bladder cancer faster and perhaps reduce the use of more invasive procedures, researchers said.
Bridgetech Holdings International announced that the company has signed a Letter of Intent to acquire a majority interest in Clarity Imaging International, the Texas based diagnostic imaging and imaging guided therapeutic company.
Rockwell Medical Technologies, a hemodialysis concentrate manufacturer in the healthcare industry, announced that it has signed a series of supply contracts with several U.S. hemodialysis providers.
Abbott and Nihon Kohden announced that they have entered into an agreement for the commercialization of automated hematology diagnostic instruments for use in hospital laboratories and physician offices.
Biosite, a research-based provider of novel, rapid medical diagnostics, announced the U.S. launch of its new, rapid, quantitative Triage D-Dimer Test.
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