FDAnews Device Daily Bulletin
March 11, 2005 | Vol. 2 No. 50
Boston Scientific has completed enrollment in its three-year ENTERYX Procedure clinical trial, designed to collect and analyze "real-world" clinical outcomes, and safety and efficacy data on the ENTERYX Procedure for patients suffering from gastroesophageal reflux disease (GERD) symptoms.
Apogee Technology, a global provider of silicon-based innovations for specialized commercial applications, has signed an agreement with the University of Medicine and Dentistry New Jersey's (UMDNJ) Laboratory for Drug Delivery to conduct research and testing on the company's proprietary, MEMS-based transdermal drug delivery device.
The FDA has conducted a review of Biofield's request for reclassification of the Biofield Breast Proliferation Rate Detection System that is intended as an adjunct that may support other modalities such as mammography, clinical breast exam, sonography and magnetic resonance imaging used in breast cancer diagnosis.
Toshiba America Medical Systems has introduced a new optimized cardiac configuration for the Excelart Vantage, the company's 1.5-tesla, high-field magnetic resonance imaging (MRI) system equipped with one of the shortest magnets in the industry.
Medical International Technology, a developer and manufacturer of patented needle free jet injectors for human and animal inoculation, announced the sale of 25 of its MED-JET -- MBX low pressure needle-free injectors designed for anesthetics use to Winsor (Hong Kong).
Bridgetech Holdings International announced that the company has signed a letter of intent to form Evit Asia with Evit Labs U.S. to manufacture and distribute the Sonik LDI 20 portable nebulizer and other inhalation therapy products throughout Asia.
Protein Polymer Technologies (PPTI) announced that its licensee, Spine Wave, has notified PPTI of its intent to expand European human clinical testing of NuCore Injectable Disc Nucleus (IDN), an injectable protein polymer formulation for repair of spinal discs damaged as a result of injury or aging.
TechniScan Medical Systems (TMS), a Salt Lake City-based developer of ultrasound technology for breast imaging, announced that it has successfully completed its latest round of financing.
Amsterdam Molecular Therapeutics (AMT) announced the appointment of Ronald Lorijn as chief executive officer.
Medwave has released its new enhanced OEM module developers kit, which allows medical device manufacturers to sample the Medwave blood pressure technology in a development setting without investment in engineering resources or time.
Agilent Technologies and Bruker Daltonics, an operating company of Bruker BioSciences, announced a multi-year extension of their ion trap mass spectrometry (ITMS) collaboration and liquid chromatography/capillary electrophoresis (LC/CE) OEM agreement.
The complete portfolio of Transfluor technology assets has been purchased from Xsira Pharmaceuticals for $11 million in cash by Molecular Devices, which makes bioanalytical tools.
Astra Tech, the medical device company, announced FDA approval and the availability of OsseoSpeed, a unique fluoride modification to the TiOblast surface that promotes faster bone growth and improves on the clinically documented TiOblast surface for optimal treatment outcomes in dental implant surgery.
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