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C4 Imaging and Isoray Celebrate FDA Clearance


C4 Imaging’s Sirius Positive Signal MRI Marker receives FDA 510(k) clearance for use with Isoray’s Cesium-131.

Medical device company, C4 Imaging, has announced that Isoray Medical, has received FDA 510(k) clearance for the use of C4 Imaging’s Sirius® positive-signal MRI (Magnetic Resonance Imaging) Markers with Isoray’s Cesium-131, brachytherapy seeds.

Sirius is implanted during the treatment of prostate cancer with brachytherapy and is used to facilitate brachytherapy seed localization within the prostate utilizing a single post-implant MRI procedure. This allows the benefits of MRI assisted brachytherapy, also known as MRI assisted radiosurgery or MARS™, to be made available to all prostate cancer patients treated with brachytherapy.

“This is a significant milestone,” said Andrew Bright, President and CEO of C4 Imaging. “Sirius MRI Markers will enable Isoray’s customers to fully utilize the benefits of MRI seed localization.” He added, “We’re delighted to partner with Isoray. They are leading innovators in the use of brachytherapy to treat prostate cancer, as well as other tumors, and recognize the potential of MRI to optimize treatment quality and patient care.”

Isoray CEO Lori Woods commented, “This achievement represents another step forward in Isoray’s leadership in providing effective prostate cancer therapeutic tools to patients and the doctors who treat them. We are excited to partner with C4 Imaging and bring together the benefits of their innovative technology and our proprietary isotope to achieve new strides in the ongoing fight against prostate cancer.”

Brachytherapy, or internal radiation therapy, is a leading, cost-effective option for the treatment of prostate cancer. Isoray is the world’s only producer of Cesium-131, commercially known as Cesium Blu™, brachytherapy seeds. Cesium-131 is a radioactive isotope that delivers a minimally invasive and highly targeted treatment to the site of the cancer preserving healthy tissue and organs. Patients benefit from the rapid resolution of their side effects allowing them to return to their normal lives quickly.

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