Leo Cancer Care has received 510(k) clearance from the FDA for its Marie radiotherapy system, an upright patient positioning platform designed to work with fixed particle beams.

The Marie system combines upright positioning with integrated CT imaging, offering an alternative to conventional particle therapy setups that depend on rotating gantries. By rotating the patient instead of the radiation beam, the system aims to reduce installation complexity, cut costs, and streamline facility design.

The Horsham, U.K.-based company says Marie is compatible with a wide range of particle therapy technologies, including proton, carbon ion, BNCT, and FLASH therapy. Its upright configuration is also intended to limit anatomical shifts during treatment, which can be a concern with traditional supine positioning—particularly in thoracic and abdominal cases.
“This clearance marks a major milestone not just for Leo Cancer Care, but for the future of cancer treatment,” said Stephen Towe, CEO of Leo Cancer Care. “We’ve long believed there’s a more human way to deliver radiotherapy — one that prioritizes the patient experience while embracing smarter, more compassionate design. Marie is the embodiment of that belief.”

In addition to its technical features, Leo Cancer Care positions Marie as a more patient-centric approach to radiotherapy, citing potential benefits such as increased comfort and reduced anxiety during treatment. The company is currently working with hospitals around the world to support clinical research on upright therapy and expand its adoption.

Marie’s FDA clearance comes amid growing interest in alternative radiotherapy delivery models, particularly those that reduce physical and financial barriers to advanced cancer treatment.

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