Computer Motion Hires Vice President of Clinical, Regulatory and Quality Affairs; New Executive to Lead Company's Clinical Study Programs and Regulatory Approval Strategies.Business Editors SANTA BARBARA, Calif.--(BUSINESS WIRE)--Dec. 20, 1999 Computer Motion Inc. (Nasdaq:RBOT RBOT Rotating Bomb Oxidation Test ) announced today it has named Richard J. DeRisio to the position of vice president of clinical, regulatory and quality affairs. DeRisio will be responsible for the strategic development of Computer Motion's clinical and regulatory processes and how they integrate into the company's overall business strategy. DeRisio has more than 15 years in the medical device industry, 10 of which were spent working for Johnson & Johnson. He most recently served as the vice president, quality & compliance and vice president, clinical, regulatory and quality at Biosense Webster Inc. (a division of Johnson & Johnson). DeRisio also spent 10 years working for the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ), where his responsibilities included engineering and technical review, management of device foreign inspection activities, Good Manufacturing Practices (GMP GMP (guanosine monophosphate): see guanine. ) compliance and providing guidance on sterilization and microbiological control. "Computer Motion is thrilled to have Mr. DeRisio join our team," said Robert W. Duggan, chairman 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 Computer Motion. "With his background with the FDA and the medical device industry, Dick has developed significant regulatory experience with Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) studies, 510(k) approvals and Premarket Approvals (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) for cardiovascular devices. "Bringing Dick on board with his FDA experience in Class II and Class III medical devices reinforces our commitment to ensure that Computer Motion meets or exceeds all requirements and expectations of the FDA and other regulatory approval agencies worldwide," added Duggan. DeRisio commented, "I am excited to be a part of the team that will bring this innovative technology to doctors and their patients in the United States. Computer Motion has assembled a remarkable group of employees who are passionate about robotically assisted surgery and the benefits we believe it brings to health care." DeRisio received a B.S., Chemical Engineering and an M.S., Food Science & Technology with a Minor in Microbiology from Cornell University. He is also a member of the Association for the Advancement of Medical Instrumentation (AAMI AAMI Association for the Advancement of Medical Instrumentation AAMI Age Associated Memory Impairment AAMI American Ammunition, Inc (stock symbol) AAMI Australian Associated Motor Insurers Limited AAMI African-American Male Initiative ), the Regulatory Affairs Professional Society (RAPS) and the Editorial Advisory Board for Medical Device & Diagnostic Industry magazine. Computer Motion is creating the cornerstone technologies and products for tomorrow's Intelligent Operating Room(TM). The company develops, manufactures and markets proprietary computer-enhanced and robotic surgical systems which enhance surgeons' capabilities, improve outcomes and reduce costs. Computer Motion markets the AESOP Aesop (ē`səp, ē`sŏp), legendary Greek fabulist. According to Herodotus, he was a slave who lived in Samos in the 6th cent. B.C. and eventually was freed by his master. (R) 3000, a voice-controlled endoscope positioning system; the HERMES(TM) Control Center, a centralized system which enables the surgeon to voice control a network of "smart" medical devices; and the ZEUS(TM) Robotic Surgical System for new minimally invasive microsurgical procedures, such as beating heart Endoscopic Coronary Artery Bypass Grafting (E-CABG(TM)). The ZEUS System is currently under an FDA-approved investigational device exemption and is CE Marked for commercial sale in Europe. ZEUS is being co-marketed by Computer Motion and Medtronic (NYSE NYSE See: New York Stock Exchange :MDT MDT abbr. Mountain Daylight Time MDT (in the US and Canada) Mountain Daylight Time MDT n abbr (US) (= mountain daylight time) → ). The company's Internet Web site is www.ComputerMotion.com. This news release contains forward-looking statements concerning the company's business and products. Actual results may differ materially depending on a number of risk factors, including the risks of competition and competing technologies, duration or suspension of clinical studies, regulatory clearances and approvals, and physician, hospital and payor acceptance of the company's products. These factors and other risks inherent in the company's business are described from time to time in the company's Securities and Exchange Commission filings, including its Annual Report on Form 10-K. The company undertakes no obligation to revise the forward-looking statements contained herein to reflect events or circumstances after the date hereof to reflect the occurrence of unanticipated events. |
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