Varian wins US, European clearance for radiotherapy systems

RefleXion Medical announced today that the FDA cleared its Scintix biology-guided radiotherapy treatment for cancer.

Hayward, California-based RefleXion designed the Scintix platform for use in treating both early- and late-stage cancers.

The company said Scintix is the first and only radiotherapy that allows each cancer’s unique biology to autonomously determine how much radiation to deliver. This occurs on a second-by-second basis during the actual treatment delivery.

Clearance by the FDA expands the RefleXion X1 system into a dual-treatment modality platform. It can now treat patients with indicated solid tumors of any stage. Scintix tracks tumor motion from all types of movement, including expected motion from internal processes like breathing and digestion. X1 also features a state-of-the-art anatomic modality cleared by the FDA for solid tumors located anywhere in the body.

Dr Terence Williams, chair of City of Hope’s radiation oncology department, said Scintix “ushers in a new era of external-beam radiotherapy.”

“We are excited to be among the early adopters of Scintix and to help develop this therapy for all cancer patients, especially those with stage 4 disease, where treatment options often remain very limited,” he said. “With Scintix, the X1 machine and the tumor communicate continuously via a live data stream produced during patient treatment. This precision should enable us to treat less surrounding tissue and may enable the treatment of more tumors in the same course of therapy.” MassDevice