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Fdanewsdevicedailybulletin

Jan. 28, 2005

Vol. 2 No. 20

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ARIAD Announces Collaboration With Medinol

ARIAD Pharmaceuticals has entered into nonexclusive agreements with Medinol to develop and commercialize stents and other medical devices to deliver ARIAD's mTOR inhibitor, AP23573, to prevent reblockage of injured vessels following stent-assisted angioplasty.

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Edwards Lifesciences Realigns Its Japan Business

Edwards Lifesciences is realigning its business in Japan as part of the company's continued efforts to focus on its core cardiovascular businesses as it transforms into a faster-growing, more profitable company.

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TranS1 Announces Commercial Launch of AxiaLIF System

TranS1, a medical device firm focused on developing minimally invasive product solutions for the treatment of lower back pain, has announced the U.S. market release of its Axial Lumbar Interbody Fusion (AxiaLIF) System.

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Thoratec Comments on HeartMate II Clinical Study Filing

Thoratec commented on its investigational device exemption (IDE) application to the FDA to conduct a Phase II pivotal clinical trial for the company's HeartMate II.

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Avanca's One-Handed Syringe Earns FDA's Nod

Avanca Medical Devices, a private company spun from the University of New Mexico in March of last year, has received approval from the FDA to market two versions of its reciprocating syringe.

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Neich Medical Acquires Orbus Medical Technologies

Neich Medical has acquired Orbus Medical Technologies. Both companies specialize in the field of innovative cardiovascular therapies.

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MedX, Extendicare Partner to Provide Phototherapy in Ohio

MedX Health, developer, manufacturer and distributor of innovative phototherapy devices, has announced a partnership with Extendicare Health Services nursing facilities in Ohio to enhance rehabilitation treatment and quality of care for patients.

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Natus Signs Five-Year Distribution Agreement With GN Otometrics

Natus Medical has signed a new five-year marketing and distribution agreement with GN Otometrics, a subsidiary of GN Store Nord A/S.

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Stephen Fanning Named New President and CEO of Thermage

Thermage, a medical device company that manufactures and markets noninvasive treatments to tighten and contour skin, named Stephen Fanning as its new president and CEO.

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Chembio Diagnostics Launches Cost-Effective HIV Stat-Pak Dipstick

Chembio Diagnostics, a developer and manufacturer of rapid tests for HIV and other infectious diseases, has launched its third HIV rapid test, HIV Stat-Pak Dipstick, to complete its unique suite of three rapid HIV tests for use in HIV testing programs in international settings.

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iCAD Releases Second Look 700 CAD System

iCAD, which designs, develops and markets Computer Aided Detection (CAD) imaging technology and systems for the early detection of breast cancer and other medical applications, has released its Second Look 700 CAD solution.

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PREVU POC Skin Sterol Test Available in Canada, U.S. Markets

IMI International Medical Innovations has announced that PREVU Point of Care Skin Sterol Test, a noninvasive, predictive test for coronary artery disease, is now available for sale in Canada and the U.S. PREVU, which measures the amount of cholesterol, or sterol, accumulated in the skin tissues, is marketed and distributed worldwide by McNeil Consumer Healthcare.

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