Cardiac Mariners Receives Marketing Clearance From FDA; X-Ray Imaging System Provides Scatter-Free Images at Lower Radiation Dose.LOS GATOS Los Gatos (lôs gä`tōs, lŏs, găt`əs), city (1990 pop. 27,357), Santa Clara co., W Calif.; inc. 1887. It is an affluent residential community and health resort. , Calif.--(BW HealthWire)--Oct. 1, 1998--Cardiac Mariners Inc. today announced that it has received clearance from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for its X-ray imaging system for fluoroscopic Fluoroscopic (fluoroscopy) An x-ray procedure that produces immediate images and motion on a screen. The images look like those seen at airport baggage security stations. Mentioned in: Hypotonic Duodenography applications. This permits the company to begin marketing a high-performance, low-radiation dose X-ray fluoroscopy fluoroscopy /flu·o·ros·co·py/ (fldbobr-ros´kah-pe) examination by means of the fluoroscope. fluo·ros·co·py n. Examination by means of a fluoroscope. Also called radioscopy. system based on its proprietary Scanning-Beam Digital X-ray (SBDX(tm)) technology. The company's first products will be for the interventional cardiology interventional cardiology Cardiology The subspecialty of cardiology dedicated to the diagnosis, medical and mechanical therapy, pre- and post-procedure management of adult patients with acute and chronic forms of cardiovascular disease amenable to catheter-based market. Cardiac Mariners' SBDX technology is a fundamentally different approach to X-ray fluoroscopy designed to overcome the image-quality limitations, radiation exposure levels, and heat-induced shutdowns common among conventional systems. Unlike the two-dimensional shadowgram images of conventional systems, SBDX produces a direct digital image, similar to the technique used in Computed Tomography Computed tomography (CT scan) X rays are aimed at slices of the body (by rotating equipment) and results are assembled with a computer to give a three-dimensional picture of a structure. (CT) scanners. SBDX-generated images are virtually scatter-free, resulting in higher quality images at reduced radiation exposure levels. According to Ron Rankin, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Cardiac Mariners, "Since the SBDX-based system produces essentially scatter-free images, physicians are better able to see small, low-contrast objects within the body. This improved visibility is a matter of increasing importance with the development of thinner and more flexible interventional cardiology devices. Moreover, because of this unique design, the system significantly reduces the radiation exposure of physicians, patients, and medical staff members during lengthy interventional procedures." The company plans to ship its first products in 1999. About Cardiac Mariners Cardiac Mariners Inc., based in Los Gatos, is a privately held medical device company formed to develop, manufacture and market unique, high-performance, low-dose X-ray imaging systems. Incorporated in 1991, the company's products are based on a proprietary operating system that represents the most fundamental change in X-ray imaging technology in the past 40 years. The company holds 10 U.S. patents covering this technology. Cardiac Mariners Inc, the Cardiac Mariners logo, and SBDX are trademarks, or registered trademarks of the company. |
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