FDAnews Device Daily Bulletin
March 22, 2005 | Vol. 2 No. 57
Prescription skin medication maker Medicis Pharmaceutical has agreed to purchase Inamed, a maker of breast implants and obesity treatments, for roughly $2.8 billion in cash and stock.
MIV Therapeutics (MIVT), a developer of next-generation biocompatible coatings and drug delivery technologies, has executed an agreement to acquire SagaX Medical Technologies, a company developing a range of proprietary solutions that decrease the likelihood of strokes and other complications from cardiac procedures as well as naturally occurring cardioembolic strokes.
HeartSine Technologies is initiating a worldwide recall of some samaritan automatic external defibrillators (AEDs) -- specifically, models SAM-001, SAM-002 and SAM-003 with certain serial numbers within the range of 1270-2324 -- because they may shut down before delivering a shock, which could result in the delayed treatment or death of a viable patient.
Boston Scientific said it has not had any settlement discussions with Israeli stent maker Medinol, the company's former partner, contrary to an Israeli news report.
Diagnostic products maker Trinity Biotech has acquired the business of Research Diagnostics (RDI) for $4.2 million in cash. New Jersey-based RDI provides a comprehensive range of immunodiagnostic products to research facilities, pharmaceutical companies, laboratories, diagnostic manufacturers and universities worldwide.
Advanced Refractive Technologies, a developer and marketer of innovative technologies for the ophthalmic surgical market, has received approval from the Health Ministry of Japan to market and sell its EpiLift System, a medical device that enables a potentially safer form of laser eye surgery called Epi-LASIK.
Positron, a manufacturer of positron emission tomography (PET) scanners, announced that it had received the final installment of funds from sale of $2 million worth of 10 percent convertible promissory notes to IMAGIN Diagnostic Centres, a private Canadian company engaged in the development of PET centers.
Varian Medical Systems announced that, under a two-year agreement, it will be supplying Xoran Technologies with Varian's PaxScan amorphous silicon flat-panel digital X-ray detectors for incorporation into Xoran's MiniCAT for ENT scanners, for imaging by ear/nose/throat physicians.
IVMD has filed for a 12th patent for its medical diagnostic technology.
HealthpointCapital Partners announced the purchase of Alphatec Manufacturing.
Tensys Medical introduced the TL-150, the only continuous, noninvasive blood pressure monitoring system with accuracy clinically proven equivalent to an arterial line.
Transgenomic has concluded negotiations with Laurus Master Fund aimed at firming up its financing for ongoing operations.
Predictive Diagnostics (PDI), a wholly owned subsidiary of Large Scale Biology, announced that it is collaborating with the University of Utah Research Foundation (UURF) to identify biomarkers from a simple maternal blood test for the early diagnosis of pregnancy-related complications and disorders such as preterm birth and preeclampsia.
VISX announced has received approval from the FDA to market and sell CustomVue treatments for mixed astigmatism.
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