FDAnews Device Daily Bulletin
May 19, 2005 | Vol. 2 No. 99
NuVasive, a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, has launched its SpheRx Dual Ball Rod (DBR) Minimally Disruptive Fixation System for percutaneous posterior spinal fixation.
Trimedyne has entered into a license agreement with Northwestern University, Evanston, Ill., for an exclusive license to the Hydrostat, a device that measures the resistance (opening pressure) of the sphincter valve of the esophagus.
Somanetics has announced that results of a clinical study showed that avoidance of cerebral oxygen desaturations in actively managed diabetic coronary artery bypass graft (CABG) patients using Somanetics' INVOS Cerebral Oximeter brain oxygen monitoring system was associated with significantly improved clinical outcomes, to the level of nondiabetic patients.
Mentor, a supplier of medical products in the U.S. and internationally, announced the U.S. launch of its new Aris Trans-Obturator Tape.
Natus Medical announced that the company was awarded a three-year, dual-source capital equipment supplier agreement for infant hearing screening products by Novation, the supply company of VHA and the University HealthSystem Consortium (UHC).
ReGen Biologics, an orthopedic products company that develops, manufactures and markets innovative products for human tissue repair in the U.S. and abroad, announced that five-year follow-up data from its feasibility study regarding the company's patented Collagen Meniscus Implant (CMI) has been published.
Escalon Medical filed a complaint against IntraLase in the Court of Chancery of the State of Delaware for breach of contract and breach of fiduciary duty arising out of IntraLase's bad faith conduct under, and multiple breaches of, a license agreement for laser technology.
Viasys Healthcare said it agreed to purchase home ventilator and respirator maker Pulmonetic Systems for $98 million in cash in a move to expand into the home products market.
Calypte Biomedical said it signed a manufacturing and management deal with newly formed Maxim Biomedical for some of its diagnostic tests for the AIDS virus.
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