Alliance Medical Corporation Receives 510(K) Clearance for Ultrasound Catheter
Posted on: Monday, 17 October 2005, 09:00 CDT
Alliance Medical Corporation (Alliance), the nation's leading reprocessor of single-use medical devices (SUDs), today announced U.S. Food and Drug Administration (FDA) clearance for Alliance to reprocess Siemens Medical Solutions' AcuNav(TM) Ultrasound Catheter. This device, which is used in the diagnosis of certain cardiac arrhythmias, offers the clinician a superior diagnostic tool.
"Alliance is committed to offering safe and affordable options to our customers," said Rick Ferreira, president of Alliance Medical Corporation. "Through reprocessing the AcuNav Ultrasound Catheter, a highly specialized and expensive cardiovascular device, more hospitals can now afford to offer their patients the enhanced medical diagnostics of the AcuNav catheter. Alliance's reprocessing program for this durable and highly engineered catheter will save our cath lab partners, their patients and the health care system over $1,500 per procedure."
"Alliance and the FDA continue to have an excellent working relationship as evidenced by the company receiving its industry-leading 31st 510(k) clearance," said Don Selvey, vice president of regulatory affairs for Alliance Medical. "We pride ourselves on offering customers the greatest flexibility in their reprocessing programs through high quality medical devices."
The reprocessing industry is a highly regulated industry that is subject to all the requirements currently applicable to original equipment manufacturers (OEMs). Alliance maintains stringent requirements set forth by MDUFMA and welcomes all regulatory framework that protects patient populations.
Having safely reprocessed more than 12 million SUDs, Alliance is one of the industry's most trusted device reprocessing companies, providing hands-on support for customers. Alliance employs clinically trained and experienced service technicians and account executives who utilize its clinically focused, three-phased client support program, Assessment, Implementation and Management (AIM), to set up and manage the most efficient and effective SUD reprocessing program. The savings health care facilities achieve as a result can be used for vital patient services, new medical technology and nursing salaries; all of which lead to improved patient care.
About Alliance Medical Corporation
Alliance Medical Corporation is a leading reprocessor of specific single-use medical devices (SUDs) and has safely reprocessed more than 12 million SUDs, saving hospitals and surgery centers in excess of $150 million. Alliance goes beyond providing technically superior medical device reprocessing services to deliver guaranteed maximum supply-cost savings to leading health care organizations. Alliance is differentiated by our unwavering partnership commitment, clinical implementation expertise and dedicated field associates which together ensure that we exceed our partners' goals and expectations. The Company's services focus on reducing supply costs of hospitals and surgery centers suffering from shrinking reimbursements and increasing costs. Alliance has agreements with leading national group purchasing organizations, alliances and supply chain service firms, including VHA, HealthTrust Purchasing Group (HPG), Broadlane and University HealthSystem Consortium (UHC), as well as a number of nationally recognized hospital integrated delivery networks, including Banner Health and Henry Ford Health System that collectively represent more than 4,000 health care facilities. For more information about Alliance Medical Corporation, visit www.alliance-medical.com; or call 888.888.3433.
Source: Business Wire
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