FDA Clears Two Ultrasound Probes

SuperSonic Imagine, a company based in Aix-en-Provence, France, has received 510(k) clearance from the Food and Drug Administration for two new probes used with its ultrasound machine, the Aixplorer. The company specializes in ultrasound medical imaging.

According to the company’s release, the first of these newly approved devices facilitates musculoskeletal and sports medicine diagnoses. Called the SHL20-6 probe, it is a high-frequency transducer, shaped like a hockey stick, which provides high resolution images of muscles, tendons, ligaments and joints located either near the surface or in deep zones of the body.

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—considered by the company to be an important feature for 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, ” said Jacques Souquet, founder and CEO of SuperSonic Imagine.

Souquet said that 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 ShearWave Elastography system, which runs on the Aixplorer, allows practitioners to view and measure tissue stiffness in real-time. According to Souquet, real-time measurements are crucial for monitoring tendinopathies and examining muscular load when the muscle is in use.

While top athletes stand to benefit the most from the more powerful visualization of tendons and muscles, musculoskeletal disorders—a primary cause of work-related illness—affect the broader population as well, according to Souquet. He founded the company in 2005 and claims it can acquire images 200 times faster than conventional ultrasound systems and can image two types of waves.