Leo Cancer Care Secures FDA Clearance for Marie

Leo Cancer Care has received 510(k) clearance from the US Food and Drug Administration (FDA) for Marie®, its upright radiotherapy platform designed for particle therapy.

Marie combines an upright patient positioning system with a CT scanner to support particle therapy delivery. 

Unlike conventional systems that use large rotating gantries, the platform rotates the patient while keeping the radiation beam in position. 

This approach is designed to reduce infrastructure requirements, installation complexity and the overall footprint of particle therapy systems.

Particle therapies such as proton and carbon ion therapy are used in radiation oncology to deliver targeted doses to tumours while limiting radiation exposure to surrounding healthy tissue. 

However, the size and cost of conventional systems have limited their availability.
Marie is designed to work with several particle beam technologies, including proton, carbon ion, boron neutron capture therapy (BNCT) and FLASH therapy. 

Its upright configuration may also offer advantages for treatment planning and delivery, particularly for tumours in the chest and abdomen.

Leo Cancer Care is working with hospitals and research institutions worldwide to evaluate upright radiotherapy through clinical research and trials. .

The FDA clearance provides a regulatory milestone for Marie and supports its continued clinical development and evaluation.