RefleXion Biology-Guided Radiotherapy Gets De Novo Clearance

RefleXion Medical’s SCINTIX, a biology-guided radiotherapy that turns cancer cells into “biological beacons” that control radiotherapy delivery to tumors, has received de novo marketing authorization from the FDA to treat lung and bone tumors.

The radiotherapy is unique in its ability to detect and treat moving tumors, such as those that change location with breathing or digestion, allowing “each cancer’s unique biology to autonomously determine where and how much radiation to deliver, second-by-second, during actual treatment delivery,” the company says.

The treatment uses a radiopharmaceutical which is injected into the patient and causes the cancer cells to produce emissions which are tracked by positron emission tomography (PET). The PET scan then builds a map of where to aim the radiotherapy, which is delivered by the company’s RefleXion XI radiotherapy device.

The X1 machine and the tumor communicate continuously via a live data stream during patient treatment, enabling less treatment of the surrounding tissue and more of the tumor.