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August 8 - August 13, 2005
August 12th: Medical Ventures Receives U.S. FDA 510(k) Clearance for the Angiometrx Metricath Gemini(TM) Balloon Catheter for Peripheral Arteries
Medical Ventures Corporation, a medical technology company specializing in the development and commercialization of cardiovascular medical devices, is pleased to announce that its Angiometrx division has received U.S. FDA 510(k) clearance for the Metricath Gemini Balloon Catheter for peripheral artery procedures, which is required for Angiometrx and its U.S. distributor to begin selling and marketing the Metricath Gemini Balloon Catheter in the United States.
The Metricath Gemini may be used by clinicians whose patients who have been diagnosed with peripheral arterial disease (PAD), which is caused by a fatty build-up in the artery that blocks normal blood flow. The peripheral arteries supply blood to extremities and organs; including, the kidneys, liver, arms, legs and feet. There are approximately 400,000 peripheral interventional procedures in the U.S. yearly.
August 12th: Stryker Announces Exclusive Distribution Agreement to Enter Hip Resurfacing Market
Stryker Corporation announced today that the Company has entered into an exclusive U.S. marketing and distribution agreement with Corin Group PLC (London Stock Exchange: CRG), a leading United Kingdom-based manufacturer and supplier of orthopaedic devices, for the Cormet Hip Resurfacing System and Optimom, its large diameter articulation hip system.
The ten-year agreement should enable Stryker to be one of the first companies to offer hip resurfacing technology to patients in the United States.
Interest in hip resurfacing procedures is on the rise globally due to the bone conserving nature of the procedure and anticipated benefits related to post-operative activities and range of motion.
August 12th: "Breakthrough" For Scientists Hunting AIDS Cure
Scientists announced for the first time that they could be nearing a cure for Aids, which has already claimed 25 million lives worldwide. A decade after the development of a therapeutic drug cocktail which transformed Aids from a killer infection to a chronic disease, doctors said yesterday that they may have made the next big breakthrough. Aids is unique among infectious diseases because even after treatment with a cocktail of powerful drugs, "latent" virus remains hidden in the body's DNA and erupts as soon as treatment stops. The scientists found that combining a cheap drug called valproic acid with the existing therapeutic cocktail, the level of "latent" HIV fell dramatically. They claim they may be able to eliminate the latent HIV altogether, curing the disease.
August 11th: Pfizer Sets Guidelines on Its Advertising; Adds More Risk Information
Pfizer Inc. pledged Thursday not to advertise new medicines directly to consumers for at least six months and only to promote its impotency treatment Viagra on TV to predominantly adult audiences. The promises are part of a package of advertising changes the world's largest drug company adopted as criticism of the way medicines are promoted to patients mounts. Pfizer's move follows last week's announcement by the pharmaceutical industry of new advertising guidelines designed to better communicate benefits and risks of drugs to patients.
August 10th: Medtronic Announces FDA Approval of Real-Time Continuous Glucose Monitoring System
Medtronic announced the U.S. Food and Drug Administration approval of the Guardian RT Continuous Glucose Monitoring System for improved diabetes management.
Medtronic noted that the system displays real-time glucose values every five minutes and alerts patients when glucose levels become too high or too low. Prior to broad distribution, the company will initiate a limited market release in select U.S. cities to further evaluate training, education and reimbursement needs.
August 10th: Researchers Discover New Tumor Defense System
Researchers have discovered that tumors release fatty acids that interfere with the cells that are trying to kill them. Consequently, strategies that reduce the amount of fatty acids surrounding the tumors may give a boost to anti-cancer therapeutics. The details of these findings appear in the September issue of the Journal of Lipid Research, an American Society for Biochemistry and Molecular Biology journal.
August 9th: Boston Scientific To Loan Celsion Corporation Up To $15 Million
Celsion Corporation today announced that it had reached an agreement pursuant to which Boston Scientific Corporation (NYSE:BSX) will lend Celsion up to $15 million. The loan, which has a term expiring on February 20, 2009, will be disbursed in up to three installments and will bear interest at a rate of prime plus 1 percent. The funding of the second and third installments of the loan is subject to Boston Scientific's reasonable satisfaction with the continuing development of the Prolieve(TM) System. Celsion has the right to prepay the loan at any time and Boston Scientific may apply the outstanding principle plus accrued interest against the purchase price of the Prolieve assets or convert the outstanding principle plus accrued interest into shares of Celsion common stock at a minimum conversion price of $0.61 per share. In conjunction with the agreement the purchase price for Boston Scientific's option to purchase Celsion's Prolieve assets has been fixed at $60 million.
August 9th: Drug Makers Object To U.S. Plan For Early Warnings
Plans by U.S. regulators to release preliminary information about potential drug side effects could lead to unnecessary confusion and "irrational fears" about medicines, drug makers said on Monday. The Food and Drug Administration (FDA) has proposed a "Drug Watch" Web page that would list drug safety concerns that are being evaluated by the agency. The drug industry's U.S. lobbying group said the information the FDA was aiming to publicize "is too vague and preliminary to be of any value in making informed treatment and prescribing decisions." "Such information is ... not likely to accomplish anything other than confusion among physicians and the public and creation of irrational fears about the safety of drugs on the list," the Pharmaceutical Research and Manufacturers of America (PhRMA) said in written comments to the FDA. Releasing early information may violate a law requiring data released by federal agencies to be useful, PhRMA argued. It also said the plan may exceed the FDA's authority.
August 8th: Kodak announces new medical imaging solutions; Debuts information system for outpatient imaging centers systems offer faster, more accurate results for patients
Eastman Kodak Company introduced new medical imaging and information systems designed to enhance efficiency and improve patient care by offering faster, more accurate diagnostic results.
The new products, unveiled this week at the annual meeting of American Healthcare Radiology Administrators, include a digital imaging system and software that improves image analysis and information management.
The introduction of these new products comes at a time when healthcare facilities are replacing traditional x-ray film with digital imaging systems that provide enhanced image quality and flexibility.
August 8th: Philips Completes Acquisition of Stentor
Philips Medical Systems, a division of Royal Philips Electronics announced that it has completed the acquisition of a 100% stake in Stentor Inc. On July 6, 2005, Philips first announced its intention to acquire Stentor, a leader in the distribution, management, and storage of digital medical images. The acquisition is designed to strengthen Philips position as a primary supplier of technology to the Healthcare Information Technology (IT) market. As a result of this acquisition, Philips now ranks globally as the number 2 supplier of picture archive and communications systems (PACS).
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