SonoSite, Inc. (Bothell, WA, USA), a developer in hand-carried ultrasound for the point-of-care, announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance for its fifth-generation, high-performance Edge ultrasound system. The company is now is shipping the system to US customers.

Designed with physician feedback in mind, the Edge system reaches a new level of clinical performance and product design, arming physicians with a tool to deliver better, safer and improved patient care. The company is now commencing US customer deliveries. International deliveries are pending CE marking. “We are encouraged by the timely regulatory review process, which represents a collaborative effort by many. We look forward to adding this new tool to our core markets and providing physicians with the impact they have been asking for in healthcare delivery.”

“The Edge system is a tremendous product and we are excited to bring it to point-of-care medicine,” said Kevin M. Goodwin, SonoSite’s president and CEO. “We are encouraged by the timely regulatory review process, which represents a collaborative effort by many. We look forward to adding this new tool to our core markets and providing physicians with the impact they have been asking for in healthcare delivery.”

“The SonoSite Edge ultrasound system provides brighter, crisper images with improved detail,” said Robert Blankenship, MD, FACEP, medical director, St. Vincent Medical Center Northeast, ultrasound director, St. Vincent Emergency Physicians, Indianapolis. “Anytime image quality is enhanced, my ability to make clinical decisions is also improved. It can be hard dealing with the bright lights and volatile environment of the emergency department; the redesigned black, backlit keyboard, brighter high-resolution display, and aluminum frame in the Edge system are great enhancements. Overall, the Edge system maintains the durability that I depend on from SonoSite, while improving the design and appeal of ultrasound.”

The system features new imaging algorithms, enabling clinicians to visualize images distinctly, while reaching deeper levels of penetration. The Edge system also features a high luminance light-emitting diode (LED), high-resolution 12-inch display, which is the company’s largest monitor to date--making it easier for clinicians to see the image from across the bed during procedures. The Edge introduces a new level of clean-ability with its sealed silicone keypad--reinforcing SonoSite’s ongoing commitment to assist medical facilities in the reduction of hospital spread infections.

The ultrasound system and transducers are the latest products to pass SonoSite’s rigorous durability standard--the three foot drop test. With a highly integrated architecture, new titanium shell and aluminum core, the Edge system can withstand the toughest and most demanding clinical environments. Moreover, the Edge system weighs less than 10 pounds and includes a five-year warranty.

At introduction, the Edge system is available with a complement of 14 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.

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