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January 11, 2018

FDA clears Xcision’s radiation therapy system for breast cancer

Xcision Medical Systems has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its GammaPod Stereotactic Radiotherapy System.

Xcision Medical Systems has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its GammaPod Stereotactic Radiotherapy System.

GammaPod is a non-invasive external beam system that is optimised for partial breast treatments with stereotactic radiotherapy, which delivers high doses in single or multiple large fractions.

After set up on the GammaPod, the patient is rotated by a robotic system from standing to the prone position to ensure better sparing of critical structures such as the heart, when compared to other radiation therapy techniques used for breast cancer.

Xcision Medical Systems founder and CEO Cedric Yu said: “Every aspect of the GammaPod system has been optimised to non-invasively treat targets within the breast using highly conformal dose distributions.

“We set out to design a solution in a real-world clinical setting that would be more convenient for patients.”

“We set out to design a solution in a real-world clinical setting that would be more convenient for patients, more efficient for hospitals and clinicians, and more cost-effective for our healthcare system.”

The stereotactic radiotherapy system is set to be studied at various GammaPod research consortium clinical trial sites such as the University of Maryland and UT Southwestern Medical Center.

Through these trials, the firm aims to validate the use of ultra-accelerated stereotactic partial breast irradiation to provide equivalent or superior local control with less toxicity.

The trials will be led by University of Maryland School of Medicine radiation oncology assistant professor Elizabeth Nichols, who expects that GammaPod could potentially identify a subset of patients not requiring surgery.

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