The FDA radiological devices advisory panel said that there wasn’t enough evidence backing the use of irradiation to prevent metastasis in the blood of cancer patients, especially given the treatment’s known risks.
Blood irradiators used to prevent cancer metastasis in the blood may need to be regulated under the US Food and Drug Administration’s highest-risk class III due to limited information, an agency advisory panel concluded at its 7 November meeting.
The radiologic devices advisory panel convened to make recommendations on the categorization of “blood irradiator devices intended to be used for the irradiation of intra-operatively salvaged blood for cancer patients...
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
