FDA Clears Radiotherapy System with 20-Fold Increase in PET Imaging Sensitivity for Tumor Detection

The Food and Drug Administration (FDA) has granted 510(k) clearance for the radiotherapy platform RefleXion® X2 with SCINTIX® therapy for the detection and treatment of lung and bone tumors.

RefleXion Medical, the manufacturer of the RefleXion X2 platform, said the system has quadrupled the field of view for the system’s positron emission tomography (PET) detector technology from 5 cm with the first-generation system to 20 cm. The RefleXion X2 system also offers a 20-fold increase in PET sensitivity for tumor detection, according to the company.

Providing sharper images with bolstered visualization of moving tumors, RefleXion Medical emphasized that the wider field of view with RefleXion X2 may facilitate earlier detection of tumors and metastatic disease.

“We have effectively expanded the 'eyes' of the machine to generate more real-time data over a larger portion of the patient’s anatomy, thereby covering the expected range of tumor motion during treatment,” noted Sam Mazin, Ph.D., the chief technology officer (CTO) and co-founder of RefleXion Medical.