CE Mark For SonoSite’s New Edge Ultrasound System

“As a faithful SonoSite user, I want the company’s products to remain true to its core elements, namely user friendliness, simplicity of use and rapid acquisition of a great image”


SonoSite, Inc. the world leader and specialist in hand-carried ultrasound for the point-of-care, announced it has received CE Marking (Conformité Européenne) in the European Union to market its next generation point-of-care product: EDGE™ ultrasound system. The EDGE system is currently available for sale in the U.S., following receipt of FDAi Premarket Notification 510(k) clearance in November. SonoSite is now commencing international customer deliveries.


Engineered with new state-of-the-art technology, the EDGE ultrasound system takes point-of- care ultrasound to a whole new level of clinical performance and enables physicians to deliver the highest standard of patient care by driving greater efficiencies and the potential for improved outcomes in the hospital and office.

The EDGE ultrasound was formally introduced in November and the company has subsequently entered into an agreement to be taken over by Fujifilm.

Clinician comments

“As a faithful SonoSite user, I want the company’s products to remain true to its core elements, namely user friendliness, simplicity of use and rapid acquisition of a great image,” said Amit Pawa, MD, Consultant Anaesthetist at Guy’s and St. Thomas’ NHS Foundation Trust, London, UK. “The EDGE system clearly accomplishes this while looking futuristic, sleek and sophisticated. Physicians will also benefit from the back-lit screen and wipe-able keypad. Overall, the image quality is superior and I can’t wait to use it in clinical practice.”

“I always expect SonoSite’s systems to have an innovative design, but now that I have just seen the EDGE system and I can say the name says it all,” said Guillermo Álvarez Rey, MD, AMS Sports Medicine Center, Málaga, Spain. “It is cutting-edge and marks a new standard for all hand-carried ultrasound systems on the market. Its design is elegant, modern, compact and robust. The large image size is excellent and I was surprised by the soft touch of the keypad. As a musculoskeletal physician, I use the HFL50 transducer frequently and was amazed at the better definition of the tissue, especially when imaging the nervous system; it’s great!”

“With the new EDGE system, SonoSite once more demonstrates its outstanding performance in image quality,” said Med Wolf Armbruster, MD, Chief Physician, Clinic of Anesthesiology, Intensive Care and Pain Management, Unna, Germany. “While using a linear probe on other ultrasound products, deeper tissue structures can hardly be seen, but the EDGE system produces images of high contrast at depth. Fascias are visible and clear, and detailed and difficult imaging areas are virtually eliminated, which is especially helpful for neurosonography. With SonoSite’s well-known reliability and robustness, the new system design and outstanding image quality makes the EDGE product the best hand-carried ultrasound system available for anesthesiology.”

Visualize with Greater Confidence

For overall improved detail and contrast resolution, the EDGE ultrasound system is engineered with new proprietary imaging algorithms that reduce speckle noise. The system also boasts a high luminance LED, high resolution 12 inch display, making it easier for clinicians to see the ultrasound image from across the bed during procedures.

The EDGE system also features a sealed silicone keypad for a new level of clean-ability – reinforcing SonoSite’s ongoing commitment to assist medical facilities in the reduction of hospital spread infections.

Product and Transducer Versatility

For departmental flexibility, the EDGE system’s transducers are compatible with SonoSite’s M-Turbo® and S Series™ systems. At introduction, the EDGE ultrasound is available with thirteen 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 SonoSite Performance and Durability Standard

Dedicated to providing the most robust products, the EDGE ultrasound system and transducers are the latest products to pass SonoSite’s rigorous durability standard– the one meter drop test. With a highly integrated architecture, magnesium shell and new aluminum core, the EDGE system can withstand the harshest and most demanding clinical environments. Also, the EDGE system weighs less than 4.5 kilograms and includes an industry leading 5-year warranty.

Source: Sonosite