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- Of chips and diapers.(topofmind)
- Last month, the Food and Drug Administration FDA approved an implantable computer chip, the VeriChip, that can pass a patient's medical history on to doctors and expedite care. It is an RFID chip made by Digital Angel Corp. Within a couple...
- Research articles 2004-11-01
- Hitachi Medical Systems America Announces FDA Clearance of Its OASIS™ MR System
- TWINSBURG, Ohio -- Hitachi Medical Systems America, Inc., a leading provider of diagnostic imaging equipment, announced FDA clearance to market its Oasis magnetic resonance imaging MRI system, the latest in the company's line of MRI products. Oasis features high performance with Hitachi's proprietary 1.2 Tesla vertical field magnet technology inclusive...
- Research articles 2007-10-02
- Fda Approves New Fonar Mri For Marketing
- MELVILLE, N.Y.--BUSINESS WIRE--April 18, 1995--FONAR Corporation symbol FONR, a leading manufacturer of magnetic resonance imaging MRI systems, and holder of the world's first MRI patent announced today that it has received FDA Food and Drug Administration approval to market its new MRI scanner, the QUADTM 7000, in the United States...
- Research articles 1995-04-18
Additional Resources
- Aurora Imaging Technology Announces Installation at Knoxville Comprehensive Breast Center
- Business Editors & Health/Medical Writers NORTH ANDOVER, Mass.--BUSINESS WIRE--Nov. 26, 2002 Aurora Imaging Technology, Inc., developer of the first FDA cleared Magnetic Resonance Imaging System designed specifically for the breast, announced the installation of the AuroraTM Dedicated Breast MRI System at the Knoxville Comprehensive Breast Center in Knoxville,...
- Research articles 2002-11-26
- Aurora Imaging Technology Announces MRI Guided Biopsy at Faulkner Hospital
- Business Editors and Health/Medical Writers NORTH ANDOVER, Mass.--BUSINESS WIRE--Sept. 30, 2002 Aurora Imaging Technology, Inc., developer of the first FDA-cleared Magnetic Resonance Imaging System designed specifically for the breast, announced its first successful biopsy procedure utilizing its MRI-guided interventional system. Physicians at the Faulkner Hospital were able to...
- Research articles 2002-09-30
- EPIX Reports Third Quarter 2004 Results and Provides MS-325 Regulatory Update; Conference call update to include recent FDA communications
- CAMBRIDGE, Mass. -- EPIX Pharmaceuticals, Inc. (Nasdaq: EPIX), a developer of innovative pharmaceuticals for magnetic resonance imaging MRI, today announced its financial results for the third quarter 2004 and provided an update on the regulatory status of the New Drug Application NDA for MS-325, the Company's lead imaging pharmaceutical designed...
- Research articles 2004-10-26
- EPIX Pharmaceuticals Files Appeal with FDA Regarding Vasovist™ Approvable Letters; Company Remains Committed To Making Novel Blood-Pool Imaging Agent Available in U.S
- CAMBRIDGE, Mass. -- EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX), a developer of innovative pharmaceuticals for magnetic resonance imaging MRI which recently announced a definitive agreement to merge with Predix Pharmaceuticals Holdings, Inc., today announced that it has submitted a formal appeal to the U.S. Food and Drug Administration FDA asking the...
- Research articles 2006-06-30
- Dedicated Breast MRI System to Serve Women of New York in the Fight Against Breast Cancer
- Business Editors & Health/Medical Writers NORTH ANDOVER, Mass.--BUSINESS WIRE--Feb. 5, 2003 Aurora Imaging Technology, Inc., developer of the first FDA-cleared Magnetic Resonance Imaging System designed specifically for the breast, announced the installation of the AuroraTM Dedicated Breast MRI System at Manhattan East Breast Imaging in New York City....
- Research articles 2003-02-05
- Toshiba Receives FDA Clearance for Vantage ZGV MRI System; MRI System Boasts Advanced Capabilities for Cardiac Imaging Applications
- ATLANTA -- Toshiba America Medical Systems Inc. TAMS today announced FDA clearance for its high-performance Excelart VantageTM ZGV magnetic resonance imaging MRI system, the most sophisticated 1.5T system in the industry. The new Vantage ZGV is immediately available and offers new product sequences, enhanced image quality, and features the Mach...
- Research articles 2006-03-11
- FDA Extends Review of EPIX Pharmaceuticals' Appeal of Vasovist™ Approvable Letters
- CAMBRIDGE, Mass. -- EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX), a developer of innovative pharmaceuticals for magnetic resonance imaging MRI which recently announced a definitive agreement to merge with Predix Pharmaceuticals Holdings, Inc., today announced that the U.S. Food and Drug Administration FDA has advised EPIX that it is extending its review...
- Research articles 2006-07-28
- Biophan Technologies Announces Research and Development Partnership with FDA to Study MRI Safety; Collaboration to Help Establish Testing Guidelines and Standards for Evaluating the Safety of Implanted Medical Devices
- ROCHESTER, N.Y. -- Biophan Technologies, Inc. (OTCBB: BIPH; FWB: BTN), a developer of next-generation medical technology, today announced that it has entered into a research partnership with the US Food and Drug Administration FDA to help improve patient safety in Magnetic Resonance Imaging MRI environments.
- Research articles 2006-05-02
- Philips Medical Systems North America, Cleveland, a division of Royal Philips Electronics, received FDA 510k clearance to market the Intera I/T. (Supplier News).(Brief Article)
- Philips Medical Systems North America, Cleveland, a division of Royal Philips Electronics, received FDA 510k clearance to market the Intera I/T, a magnetic resonance imaging system for intervention and therapy. The device includes a scanner that is optimized for interventional procedures and has...
- Research articles 2002-05-01
- Aurora Imaging Technology Receives FDA Clearance for Spectroscopy Technology
- NORTH ANDOVER, Mass. -- Aurora Imaging Technology Inc. is proud to announce that the Aurora([R]) 1.5Tesla Dedicated Breast MRI System has received 501k clearance from the U.S. Food and Drug Administration FDA for AuroraSPECTROSCOPY[TM], the company's breast magnetic resonance MR spectroscopy package. The availability of AuroraSPECTROSCOPY will provide Aurora Breast...
- Research articles 2008-11-03
- Picker's MRI workstation gains 510K approval - Picker International, ViStar medical imaging supercomputer
- Picker's MRI workstation gains 510K approval Picker International has received 510K approval fro the Food and Drug Administration for its new ViStar medical imaging supercomputer. The approval will help Picker market its $216,000 workstation because many customers hold off purchasing equipment until it is fully cleared by the FDA,...
- Research articles 1991-04-01
- E-Z-EM Receives FDA 510 Clearance for EmpowerMR Injector System
- LAKE SUCCESS, N.Y. -- E-Z-EM, Inc. (NASDAQ:EZEM) today announced that the Company has received 510k clearance from the Food and Drug Administration FDA for its EmpowerMRTM injector system--the Company's first product for the magnetic resonance MR imaging market. Building on the Company's successful Empower family of CT injector systems, EmpowerMR...
- Research articles 2007-04-16
- Aurora Breast MRI Immediately Available to Patients in Mississippi at Hattiesburg Clinic Breast Center
- HATTIESBURG, Miss. -- Aurora Imaging Technology, Inc. announced today that the Aurora([R]) 1.5Tesla Dedicated Breast Magnetic Resonance Imaging MRI System has been installed and is immediately available to patients in Mississippi at the Breast Center of Hattiesburg Clinic. Hattiesburg Clinic chose the Aurora Breast MRI System, the first and only...
- Research articles 2007-08-07
- StemCells, Inc. Announces Publication Describing Non-Invasive Tracking of Human Neural Stem Cells Transplanted in Vivo
- PALO ALTO, Calif. -- StemCells, Inc. (NASDAQ: STEM) today announced the publication of a paper describing a new technique for non-invasive tracking of human neural stem cells transplanted into the brains of mice. The technique involves tagging the human neural stem cells with Feridex[R], a commonly used magnetic resonance imaging...
- Research articles 2007-06-05
- GE Healthcare Technologies, Waukesha, WI, Feb. 22
- FDA found that the manufacturer of coils used in magnetic resonance imaging systems and breast biopsy plates did not process its complaints in a uniform and timely manner. For example, the current complaint procedure stated that PSRs safety complaints over 45 days and PQRs quality reports open over 90...
- Research articles 2007-03-26
- GE Healthcare Technologies, Waukesha, WI, Feb. 22
- FDA found that the manufacturer of coils used in magnetic resonance imaging systems and breast biopsy plates was not in full conformance with current GMP requirements of the Quality Systems regulation. The firm was cited for failure to assure that only those devices that are approved for release are...
- Research articles 2007-03-01
- Biotronik
- Biotronik, Lake Oswego, OR, June 16 (CDRH-OC). The letter stated that a journal ad for three of the firm's Phylax and its mycroPhylax cardiac devices caused the products to be misbranded due to lack of a statement of intended use and relevant warnings, precautions and contraindications. FDA sought four...
- Research articles 1999-10-25
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