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Xcision wins US FDA 510(k) clearance for the GammaPod Stereotactic Radiotherapy System for breast cancer treatment.

M2 EQUITYBITES-January 10, 2018-Xcision wins US FDA 510(k) clearance for the GammaPod Stereotactic Radiotherapy System for breast cancer treatment


Medical technology company Xcision Medical Systems, LLC reported on Tuesday the receipt of the 510(k) clearance from the US Food and Drug Administration for the GammaPod Stereotactic Radiotherapy System for breast cancer conserving surgery.

According to the company, GammaPod Stereotactic Radiotherapy System is the world's first noninvasive external beam system optimized for partial breast treatments using highly conformal dose distribution. The sharp falloff outside the target volume results in low doses to surrounding healthy breast tissue, heart and lungs.

Following the planned launch of GammaPod, the radiation oncologists will be at the forefront of a new era in cancer care by providing stereotactic radiotherapy treatments for the breast, added the company.

The company said stereotactic treatments require a high degree of precision and geometric accuracy and patients are fitted with a breast cup immobilization device. After imaging, treatment planning is performed while the patient is set up on the GammaPod for treatment. A robotic system rotates the patient from standing to prone position, which has been shown to offer superior sparing of the heart and other critical structures compared to other radiation therapy techniques for many breast cancer patients.

Breast cancer is the most frequently diagnosed tumor site in the majority of countries worldwide, accounting for about 12% of new cases annually and 25% of cancers in women. Most of these women are eligible for breast conserving surgery, which includes lumpectomy followed by radiotherapy.

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Publication:M2 EquityBites (EQB)
Date:Jan 10, 2018
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