GMV obtains authorization for selling its intraoperative radiation therapy planning system in the USA

GMV has received official authorization from the USA’s Food and Drug Administration (FDA) to market its intraoperative radiation therapy planning system, radiance™, in the USA.

The system, a worldwide trailblazer, was developed by GMV in collaboration with the research team of the Oncology Department and the Experimental Surgery and Medicine Department of the Hospital General Universitario Gregorio Marañón, together with a set of prestigious Spanish hospitals and universities.

This revolutionary new system enables all the decisions of a surgical operation and the radiation effects on the patient to be pre-planned before the patient actually receives any radiation dose.

It is a sure and reliable method that boosts irradiation efficiency and precision in any operation, benefiting not only the patients themselves, cutting down the operation time and increasing their quality of life, but also the surgeons and oncologists, who can enter the operating theater with many of the decisions previously assessed and agreed.

The technological complexity of this and other GMV developments calls for different quality standards in its processes. For this reason radiance™ had already obtained CE Mark approval authorizing its marketing in all EU member states and has now added this authorization from the USA’s Food and Drug Administration. This means that GMV can continue its worldwide promotion and expansion process in two of today’s most important IORT markets.