FDA approves Philips non-invasive elastography for liver assessment

Royal Philips announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ElastQ Imaging capability, further expanding the functionalities of its EPIQ family of ultrasound systems. ElastQ Imaging enables simultaneous imaging of tissue and assessment of its stiffness, which is essential for the diagnosis of various liver conditions. With ElastQ Imaging, clinicians have a comprehensive solution to assess and diagnose liver conditions without the pain or expense of a liver biopsy.  Using shear wave elastography to focus sound waves to assess soft tissue stiffness, ElastQ Imaging is non-invasive, reproducible and easily executed. Philips is at the forefront of imaging technology innovation, and with this new capability, is addressing a significant need of medical professionals in the clinical setting.

Liver disease, which includes hepatitis B and C, liver cancer and cirrhosis, is a growing global health issue due in part to rising obesity rates and an aging population. Non-alcoholic fatty liver disease affects approximately 20% of the global population. According to the World Health Organization (WHO), total deaths worldwide from cirrhosis and liver cancer rose by 50 million per year over the last two decades, and many cases continue to go undetected.

To determine the stage of liver disease and damage, a liver biopsy is typically performed by extracting a small piece of liver tissue for microscopic examination. Research suggests that instead of costly and painful biopsy procedures, ultrasound exams using shear wave elastography could become routine for assessing liver disease status and may reduce or avoid the need for conventional liver biopsies.

“Philips aims to provide the tools necessary for assessing and managing chronic conditions that so many people face, and liver disease is no exception,” said Vitor Rocha, Ultrasound Business Leader at Philips. “We know that liver disease is a growing health concern around the globe, and we are committed to pioneering innovations like ElastQ Imaging to create our ultimate ultrasound liver solution that offers exceptional clinical performance, further improving patient care.”

Source: Royal Philips

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