FDA Gives Nod to Scintix Biology-Guided Radiotherapy From RefleXion

Following a pivotal breakthrough device designation, digital health solutions and therapeutic oncology company RefleXion Medical has scored an FDA marketing clearance for its pioneering, biology-guided radiotherapy (BgRT) for clinical use in testing lung and bone cancers of any stage. Scintix BgRT leverages the unique biological characteristics of cancers to target effective delivery of radiotherapy—even going so far as to force movement of tumors.

As delivered by the company’s RefleXion X1 machine, the new Scintix therapy represents the first platform to blend positron-emission tomography (PET) technology. This gold standard of cancer staging and imaging features a linear accelerator (LINAC) for guided radiation dose administration, and mitigates the chance of damaging healthy tissue in the process of treating tumors on a daily basis. Moreover, the X1 machine itself is now the only dual-treatment modality platform that can help treat any-stage long and/or bone cancers,

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Typically enabled through monitoring emissions from malignant cells after a radiopharmaceutical injection, PET has been used as a diagnostic tool for identifying cancer for quite some time. Scintix incorporates PET’s anatomic data, derived from computed tomography and functional imaging data, to bring its personalized cancer treatment radiotherapy to patients. The reduction in tissue volume afforded by Scintix therapy gives it the potential to cure polymetastatic and oligometastatic diseases in a single session.