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Fdanewsdevicedailybulletin

March 15, 2005

Vol. 2 No. 52

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MIV, Sahajanand Agree to Form Drug-Eluting Stent Company

MIV Therapeutics (MIVT), a developer of next-generation biocompatible coatings and drug delivery technologies, has executed a letter of intent to acquire Sahajanand Medical Technologies (SMT), a manufacturer of advanced coronary stents.

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FDA Approves New Cochlear Implant System

Cochlear Americas recently received approval from the FDA to market the Nucleus Freedom cochlear implant system.

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St. Jude Announces Global Launch of Its PSA Wand

St. Jude Medical has launched its first integrated pacing system analyzer (PSA) wand, which attaches to St. Jude Medical programmers and enables clinicians to conduct implantation testing and performance threshold testing, as well as programming and interrogation of pacemakers, implantable cardioverter-defibrillators (ICDs) and emerging indications devices without the need for separate analyzer hardware.

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Varian Receives FDA 510(k) for Nasopharynx Applicator Set

Varian Medical Systems has received FDA 510(k) clearance for a brachytherapy solution that enables more accurate and flexible treatment of nasopharyngeal cancer.

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BSD's BSD-2000 Receives Chinese Regulatory Approval

BSD Medical announced that the State Food and Drug Administration of the People's Republic of China has given regulatory approval for the sale of the BSD-2000 in China, well in advance of BSD's initial time projection.

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Nephros Announces 510(k) Filing for OLpur HD190 High Flux Filter

Nephros announced that it has provided a 510(k) submission for its OLpur HD190 to the FDA.

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Endo Pharma Licenses Two Pain Patches

Endo Pharmaceuticals said it licensed exclusive U.S. and Canadian rights to develop and commercialize two pain-relief patches from Durect and ProEthic Pharmaceuticals.

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Selenium, Pinpoint Med to Develop Interventional Catheter Device

Emergent Technologies of Austin, Texas, announced that one of its Lubbock-based biotechs, Selenium, has agreed with Pinpoint Med, Glil Yam, Israel, to develop an interventional catheter device which employs Selenium's patented technology.

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Bayer Launches Drug-Abuse Tests in U.S. and Europe

Bayer AG's HealthCare unit said its diagnostics division has launched a package of nine new tests to detect drug abuse in the U.S. and Europe.

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Hoana Medical Unveils Diagnostic Pad

For Hoana Medical, sales of an advanced diagnostic hospital bed may not be science fiction much longer.

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Xilas Medical Announces Completion of $1 Million Financing

Xilas Medical, a medical device company focused on diabetic foot care, announced that it has completed a $1 million Series B financing.

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Biophan Commencing Animal Trials of MRI-Visible Vena Cava Filter

Biophan Technologies, a developer of next-generation biomedical technology, announced plans to begin animal trials of its advanced MRI-imageable vena cava filter, in a research program underway at the company's newly established Biophan-Europe division.

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