The approval removes contraindications for pregnancy and active implants and includes the following:
- FibroScan can aid physicians in determining the likelihood of cirrhosis and in assessing liver fibrosis and hepatic steatosis.
- Designates FibroScan as a noninvasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease.
- The patient population has been expanded from "patients with liver disease" to "patients with confirmed or suspected liver disease."
- Age has been removed as the first selection probe and exam-type step.
- Measurement interpretation has been expanded to all physicians with appropriate training.
- The removal of "estimates of" when referring to tissue stiffness.
The company said the device can be used in risk prediction for liver disease progression and decompensation. It can also guide management decisions, evaluate treatment response, and reduce the need for biopsy, Echosens added.
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