FDAnews Device Daily Bulletin

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.

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.

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.

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.

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.

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

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.

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

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.

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.

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.

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.