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ViewRay wins FDA 510(k) clearance for MRI-based radiotherapy technology

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ViewRay Inc. received federal regulatory clearance to begin commercializing its MRI-based technology to deliver radiation therapy to cancer patients.

The Oakwood, Ohio-based company’s imaging device received clearance under the Food & Drug Administration’s 510(k) program for medical devices in January, according to the agency.

CEO Greg Ayres declined comment through a spokeswoman.

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The 510(k) clearance is a big milestone for the company as it looks to begin generating sales — and returns for the investors who’ve pushed $53 million into ViewRay. In August, the company announced that it had raised a $20 million Series C round of investment, which was led by new investor Siemens Venture Capital GmbH and joined by existing investors Aisling Capital, Fidelity Biosciences, Kearny Venture Partners and OrbiMed Advisors.

ViewRay says its technology helps doctors see exactly where radiation is being delivered to a cancer patient’s body, unlike existing technology, which doesn’t account for the movement of internal organs. That movement can cause radiation to be delivered to healthy issue, leading to harmful side effects. The company’s technology aims to solve that problem by providing continuous soft-tissue imaging for more accurate delivery of radiation therapy.

The company announced last year (PDF) that Barnes-Jewish Hospital in St. Louis, Mo. would become the first clinical institution to test its device. For ViewRay, product installation is a laborious process that lasts up to six weeks and involves implementing MRI and radiation-therapy machines in a radiation-shielded room.

ViewRay moved to Oakwood in suburban Cleveland from Florida in 2008, lured by the region’s imaging talent and tax incentives.

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