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www.fdanews.com/articles/208885-bioventus-nexus-sonastar-elite-gets-510k-clearance

Bioventus’ neXus SonaStar Elite Gets 510(k) Clearance

August 5, 2022

Bioventus’ neXus SonaStar Elite ultrasonic device has received 510(k) clearance from the FDA for removal of tumors with varying consistencies ranging from soft to firm, including malignant and benign brain and spinal tumors.

The handheld device, which uses sound waves with a frequency above the upper limit of human hearing, can do the work of multiple instruments and improve surgery times, the company said.

The tool is also designed to remove soft tissue with precision, including at the skull base and on the liver. The ultrasonic device is said to provide easy setup and do the work of multiple instruments.

Durham, N.C.-based Bioventus is focused on developing medical products for pain treatment, restorative therapy and surgical solution areas.

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