SuperSonic Imagine Receives FDA 510k Clearance for New Musculoskeletal and Vascular Ultrasound Probes
AIX-EN-PROVENCE, France, Dec. 1, 2014 /PRNewswire/ -- SuperSonic Imagine (Euronext: SSI, FR0010526814), a company specializing in ultrasound medical imaging, is pleased to announce it has received 510k clearance from the FDA for two new probes used with its ultrasound machine, the Aixplorer®.
The first of these newly approved devices facilitates musculoskeletal and sports medicine diagnoses. The SHL20-6 probe, a high-frequency transducer shaped like a hockey stick, provides very high resolution images of muscles, tendons, ligaments and joints. It complements the linear transducer range to provide unrivalled image quality for both very superficial and deep zones.
Jacques Souquet, founder and CEO of SuperSonic Imagine, notes that the Aixplorer's musculoskeletal application and hockey stick probe together have "earned very positive reactions from physicians specializing in sports medicine treatment and research." SuperSonic Imagine's patented ShearWave™ Elastography system, which runs on the Aixplorer, allows practitioners to view and measure tissue stiffness of up to 800kPa in real-time. These real-time measurements are crucial for monitoring tendinopathies and examining muscular load when the muscle is in use.
While top athletes stand to benefit most from the more powerful visualization of tendons and muscles made possible by these devices, musculoskeletal disorders affect the broader population as well. They are, for instance, the primary cause of work-related illness.
The second probe cleared by the FDA is the single crystal XP5-1 transducer, which combines high sensitivity and enhanced resolution to visualize very low blood flow—an important feature for optimal transcranial doppler (TCD) and abdominal vascular measurements. "Transducers like our SHL20-6 and the XP5-1 bring next-level imaging performance to the most difficult cases to image, helping physicians to make better diagnoses with minimal intervention," Souquet says.
SuperSonic Imagine will exhibit at RSNA 2014 Chicago in Hall A Booth 5116 from November 30 through December 4.
About SuperSonic Imagine
Founded in 2005 and based in Aix-en-Provence (France), SuperSonic Imagine is a company specializing in medical imaging. The company designs, develops and markets a revolutionary ultrasound system, Aixplorer®, with an UltraFast™ platform that can acquire images 200 times faster than conventional ultrasound systems. Aixplorer® is the only system that can image two types of waves: ultrasound waves ensure excellent image quality and shear waves, which allow physicians to visualize and analyze the stiffness of tissue in a real-time, reliable, reproducible and non-invasive manner. This innovation, ShearWave™ Elastography, significantly improves the detection and characterization of numerous pathologies in several applications including breast, thyroid, liver and prostate. SuperSonic Imagine has been granted regulatory clearances for the commercialization of Aixplorer® in the main global markets. Over the past years, SuperSonic Imagine enjoyed the backing of several prestigious investors, among which Auriga Partners, Edmond de Rothschild Investment Partners, Bpifrance, Omnes Capital and NBGI.
For more information about SuperSonic Imagine, please go to www.supersonicimagine.com.
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SOURCE SuperSonic Imagine
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