HOME > ABOUT US > PRESS RELEASES > SonoSite Announces FDA Clearance for Its New Nanomaxx Ultrasound Tool
SonoSite Announces FDA Clearance for Its New Nanomaxx Ultrasound Tool
Company now shipping the breakthrough NanoMaxx™ system to US customers
BOTHELL, WA - October 5, 2009 - SonoSite, Inc. (Nasdaq:SONO), the world leader and specialist in hand-carried ultrasound for the point-of-care, announced today that the company has received FDAi 510(k) clearance for its new NanoMaxx™ ultrasound system and is commencing US customer deliveries. International deliveries began at the end of June.
Based on SonoSite’s 4th generation Turbo technology, the six pound NanoMaxx system is the latest addition to SonoSite’s suite of specialized products for point-of-care visualization in medicine. Complete with streamlined one button optimization technology, a touch screen user interface and SonoSite’s industry-leading 5-year warranty, the NanoMaxx system is ideal for both hospital and office markets and designed to provide healthcare professionals with improved patient safety practices, expanded workflow capabilities and exam room flexibility.
Among the first to take delivery of a system, the Queensland Ambulance Service in Australia, is integrating ultrasound into their rapid response vehicle. “Ultrasound is an essential tool for providing immediate diagnostics, improving patient safety and ultimately raising the standard of patient care,” said Stephen Rashford, MD, the department’s medical director. “With a hand-carried system, our department will be able to assess and diagnose patients at the scene of an accident, such as aggressively managing chest injuries, and for higher level trauma cases, pre-notify the hospital of a patient’s arrival to guarantee the availability of an operating room.”
One Button Control for Increased Efficiency
The new ultra portable and one button design of the NanoMaxx system makes high quality ultrasound available to a much broader range of clinicians. The system incorporates SonoSite’s advanced proprietary imaging algorithms, including SonoMB™ and SonoAdapt™ to deliver superior image quality in a lightweight, rugged form factor.
With a touch screen that responds easily to the tap of a finger, and one button optimization, clinicians can readily acquire high resolution images to increase clinical productivity at the point-of-care. A system boot-up time of less than 20 seconds and long battery life further enhance workflow when using the NanoMaxx system.
Reduce Length of Stay. Improve Patient Safety.
Designed to help hospitals meet the new standards of patient care, the NanoMaxx is the perfect diagnostic ultrasound for clinical assessment and procedural guidance at the hospital bedside and in the physician’s office. The ultimate tool for reducing patient safety risks and healthcare delivery costs, the use of bedside ultrasound is proven to increase the accuracy of interventional procedures and the use of ultrasound guidance is now recommended by two government-based agencies1 and three US medical societies2.
At introduction, the NanoMaxx tool is available with a complement of five transducers to support a wide range of examinations and procedures including thoracic assessment for pathology, vascular access, needle aspirations and injections, as well as abdominal, cardiac, nerve, OB/Gyn, musculoskeletal, small parts and vascular scanning. The clinical capabilities of the NanoMaxx will help eliminate the risk and cost of transporting patients to the imaging lab for many examinations and procedures.
Mount it. Carry it. Or Use it on a Stand.
The small footprint of the system, along with its space-saving solutions, enables seamless integration with a multitude of exam-room configurations. For convenience and flexibility, the system can be wall mounted, placed on an exam table with kickstand attached, or used from a highly maneuverable stand. Physicians can easily carry the NanoMaxx tool from room-to-room, to a satellite office, to the operating room or to a field site for immediate use.
Drop Tested at 3 Feet
The NanoMaxx system’s highly integrated architecture and ruggedized design, including the industry’s first elastomeric bumper for extra durability, plus magnesium outer shell, allows it to be used in the most demanding and austere environments. Proving its reliability, the NanoMaxx system and its transducers successfully passed SonoSite’s standard three foot durability drop test.
In addition, to further reduce the risk of infection, the NanoMaxx system’s fluid-resistant user interface makes the system easy to clean and disinfect, helping to address the growing concern over infection control in the medical community.
Affordable and Easily Accessible with Web-Based Purchasing Program
Affordably priced, the NanoMaxx system and its transducers include SonoSite’s industry-leading 5-year warranty, to provide the lowest cost of ownership in ultrasound.
Also, SonoSite’s One-to-One Purchase Program further extends the cost saving advantages of the NanoMaxx ultrasound tool by replacing or complementing the traditional on-site, pre-sale demonstration with a personal phone consultation and webcast demonstration provided by a professional clinical sales consultant. Visit the NanoMaxx ultrasound tool website to learn more about SonoSite’s newest system and to experience a personal, interactive product demo. In addition, Apple® iPhone® and iPod® mobile device users can view a video of the NanoMaxx system on SonoSite’s new SonoAccess™ application.
SonoSite, Inc. (www.sonosite.com) is the innovator and world leader in hand-carried ultrasound. Headquartered near Seattle, the company is represented by ten subsidiaries and a global distribution network in over 100 countries. SonoSite’s small, lightweight systems are expanding the use of ultrasound across the clinical spectrum by cost-effectively bringing high performance ultrasound to the point of patient care. The company employs approximately 750 people worldwide.
1 Agency for Health Care Research and Quality (AHRQ) report: Making Healthcare Safer: A Critical Analysis of Patient Safety Practices 2001. National Institute for Clinical Excellence (NICE) report: Guidance on the Use of Ultrasound Locating Devices for Placing Central Venous Catheters. 2002.
2 The American Board of Internal Medicine. “Training and Procedural Requirements; Critical Care Medicine.” Critical Care Medicine Policies. 2009. The American Board of Internal Medicine. (certification/policies/imss/ccm.aspx#tpr). The American College of Chest Physicians. “Consensus Statement; La Societe de Reanimation de Langue Francaise Statement on Competence in Critical Care Ultrasonography.” 135 (2009): 1050-1060. The American College of Emergency Physicians. “Policy Statement; Emergency Ultrasound Guidelines.” 53 (2009): 550-70.
Forward-looking Information and the Private Litigation Reform Act of 1995
Certain statements in this press release relating to the market acceptance of our products, possible future sales relating to expected orders, and our future financial position and operating results are “forward-looking statements” for the purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the opinions and estimates of our management at the time the statements are made and are subject to risks and uncertainties that could cause actual results to differ materially from those expected or implied by the forward-looking statements. These statements are not guaranties of future performance and are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions. Factors that could affect the rate and extent of market acceptance of our products, the receipt of expected orders, and our financial performance include our ability to successfully manufacture, market and sell our ultrasound systems, our ability to accurately forecast customer demand for our products, our ability to manufacture and ship our systems in a timely manner to meet customer demand, variability in quarterly results caused by the timing of large project orders from governmental or international entities and the seasonality of hospital purchasing patterns, timely receipts of regulatory approvals to market and sell our products, regulatory and reimbursement changes in various national health care markets, constraints in government and public health spending, the ability of our distribution partners and other sales channels such as the physician office sales force to market and sell our products, the impact of patent litigation, our ability to execute our acquisition strategy, the effect of transactions and activities associated with our issuance of senior convertible debt in July 2007 on the market price of our common stock, and as well as other factors contained in the Item 1A. “Risk Factors” section of our most recent Annual Report on Form 10-K, as updated by our most recent quarterly reports filed on Form 10-Q filed with the Securities and Exchange Commission. We caution readers not to place undue reliance upon these forward-looking statements that speak only as to the date of this release. We undertake no obligation to publicly revise any forward-looking statements to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.
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