FDA Approved!
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| The NOGA XP cardiac- navigation system is currently being used in more than 17 clinical trials around the world to map the heart to treat such conditions as congestive heart failure and
chronic ischemia.. |
The FDA has cleared for marketing a 3-D imaging system and the only such guided electromechanical cardiac-navigation technology available to physicians for use in a variety of advanced medical procedures. The NOGA XP Cardiac Navigation System creates precise, 3-D images of the heart that can help physicians accurately identify tissue that could potentially benefit from a variety of targeted investigational therapies. The Biologics Delivery Systems Group of Cordis Corp (Diamond Bar, Calif) will distribute the NOGA XP, which was developed and is manufactured by Biosense Webster Inc (Diamond Bar, Calif), a Johnson & Johnson company.
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| Both the Innova 3131 IQ and 2121 IQ digital flat-panel biplane imaging systems from GE Healthcare can be used in cardiovascular imaging, diagnostic, and interventional procedures, as well as 3-D imaging of vessels and soft tissue. |
GE Healthcare has received FDA 510(k) clearance for the Innova 3131 IQ and 2121 IQ digital flat-panel biplane imaging systems. The Innova systems cover the full size of the patient's lateral and frontal anatomy simultaneously for a variety of cardiovascular and neurovascular image-guided interventional procedures. The increased coverage allows procedures to be completed with fewer X-ray images and contrast injections, thus benefiting the patient.
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| Hitachi's CXR16 is a main component in the company's bid to expand its participation in the US CT market. |
Hitachi Medical Systems America Inc (HMSA of Twinsburg, Ohio) has received 510(k) marketing clearance for the CXR16, the newest addition to the company's CT family. "The CXR16 is designed to participate in the large mid-tier segment of the CT market," said Mark Silverman, HMSA's CT marketing manager. "What distinguishes [the CXR16] is that important features typically sold as options on other CT systems or associated with high-tier scanners come standard on the CXR16. These features include a 7.5 MHU X-ray tube, a 72 kW generator, and a reconstruction capability of up to 40 images per second."
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| This whole-heart image (left) was captured with Toshiba's newly FDA-cleared Excelart Vantage ZGV (above right). |
Toshiba America Medical Systems Inc (TAMS of Tustin, Calif) has received FDA clearance for its Excelart Vantage ZGV MRI system, a 1.5T system that offers new product sequences and enhanced image quality. The Vantage ZGV features the Mach 8 processor, which increases reconstruction to 1,300 images per second for more powerful clinical applications. Field upgrade kits to the new ZGV are available to current Vantage users.
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| The LUMA system by MediSpectra Inc (above left) is a noncontact optical imaging device that, when used as an adjunct, detects more high-grade cervical-cancer
precursors than colposcopy alone. The system shines a light on the cervix (above right) and analyzes how different areas of the cervix respond to this light. It then assigns a score to tiny areas of the cervix and produces a color map that helps physicians determine where to biopsy. |
The LUMA cervical-imaging system from MediSpectra Inc (Lexington, Mass) has received FDA clearance. The LUMA system is the first optical imaging device approved as an aid to clinicians examining women with abnormal pap tests. The device is used immediately after a colposcopy to determine where to take additional biopsies. When used as an adjunct to colposcopy, the LUMA system is expected to reduce the number of high-grade cervical-cancer precursors (that is, lesions that are at high risk of developing cancer) that are missed when women are evaluated for abnormal pap tests.
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