FARMINGDALE, N.Y., June 18 /PRNewswire-FirstCall/ -- Misonix, Inc. (Nasdaq: MSON - News), a developer of minimally invasive ultrasonic medical device technology, which in Europe is used for the ablation of tumors and worldwide for other acute health conditions, announced today that its subsidiary, Sonora Medical Systems, Inc. (“Sonora”), one of the world’s leading suppliers of after market products, training, depot-level repair and support services, and test equipment to the medical imaging market, announced it has achieved ISO 17025 accreditation for its Acoustic Power Testing Laboratory. Acoustic power testing is a requirement for ultrasound system and probe manufacturers to obtain FDA 510(k) clearance of their products, as well as meet the International IEC60601 standards. In addition to the important foundation of a quality management system, the ISO 17025 standard specifically addresses the technical competence of the laboratory staff, the validity and appropriateness of the test methods, traceability of measurements to national standards, appropriate application of measurement uncertainty, suitability of test equipment and environment, and the quality of the test results and reports. Test data from ISO 17025 accredited laboratories is more readily accepted by worldwide regulatory and safety organizations, reducing cost and time to market globally for manufacturers.
Michael A. McManus, Jr., President and CEO of Misonix said, “This is one more validation of the ability of our employees at Sonora to develop new important acoustic power testing capability that is recognized by regulatory bodies as a high standard of accuracy and testing. Sonora performs more acoustic power testing for companies that design and develop diagnostic ultrasound systems than anyone in the world.”
“We are very proud of the professionalism of our Sonora employees. Achieving ISO 17025 accreditation further underscores our commitment to our valued customers on a world-wide basis that we will continue to improve and expand our testing facility and capabilities,” said G. Wayne Moore, President and CEO of Sonora Medical Systems. “Accreditation allows customers to make informed decisions when selecting a test laboratory. It demonstrates competence, impartiality, capability, and substantiates the credibility of test results. Sonora Medical Systems is proud to offer this important new level of service to our acoustic power test customers,” Moore continued.
In addition to offering industry unique ultrasound test devices and support service, Sonora Medical Systems is one of the largest and fastest growing ultrasound and MRI depot-level repair company in the United States. All Sonora operations are certified to the ISO9001 and 13485 quality standards.
For additional information concerning Sonora’s Acoustic Power Testing and API products go to www.4Sonora.com or contact Eddie Henry, Sonora Marketing Communications Manager: eddie@4sonora.com 303-682-5871.
About Misonix:
Misonix, Inc. (Nasdaq: MSON - News) designs, develops, manufactures and markets therapeutic ultrasonic medical devices and laboratory equipment. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $3 billion annually; Misonix’s proprietary ultrasonic medical devices are used for wound debridement, cosmetic surgery, neurosurgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s Web site at www.misonix.com.
With the exception of historical information contained in this press release, content herein may contain “forward-looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.
Investor Relations Contact: Kevin McGrath Cameron Associates, Inc. 212-245-4577 Kevin@cameronassoc.com
