SonoSite Gets FDA Clearance for Its New NanoMaxx Ultrasound Tool

Oct 10, 2009 (Close-Up Media via COMTEX) -- SONO | Quote | Chart | News | PowerRating -- SonoSite, Inc., a specialist in hand-carried ultrasound for the point-of-care, announced that the company has received FDA 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 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, the Company noted in a release.

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."

The new ultra portable and one button design of the NanoMaxx system makes ultrasound available to a much broader range of clinicians. The system incorporates SonoSite's proprietary imaging algorithms, including SonoMB and SonoAdapt to deliver image quality in a lightweight, rugged form factor.

With a touch screen that responds 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.

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 tool for reducing patient safety risks and healthcare delivery costs, the use of bedside ultrasound increases 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 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.

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 carry the NanoMaxx tool from room-to-room, to a satellite office, to the operating room or to a field site for immediate use.

The NanoMaxx system's 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.

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