Medical Devices

MRI-guided radiation therapy device from ViewRay gets FDA clearance

An MRI-based system that delivers radiation therapy to cancer patients has received 510(k) clearance from the U.S. Food and Drug Administration.

It’s a “major milestone” for Cleveland-area ViewRay, which in March closed on the last tranche of a $45 million series C investment round, according to a statement from the company. The designation from the FDA means ViewRay is free to begin marketing its system in the U.S.

The company last year received 510(k) clearance on the treatment-planning and delivery software associated with its radiation therapy system.


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 and lead 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.

Barnes-Jewish Hospital in St. Louis, Missouri is the first U.S. customer to install the ViewRay system. The University of Wisconsin’s Carbone Cancer Center is currently in the midst of an installation, according to the statement.

ViewRay’s investors include Aisling Capital, Fidelity Biosciences, Kearny Venture Partners, OrbiMed Advisors and Siemens Venture Capital. As a major imaging company, Siemens represents a potential acquirer of ViewRay.

A company representative didn’t immediately return a call.

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