RefleXion’s Radiotherapy Designated FDA Breakthrough Device for Lung Cancer

RefleXion Medical has received the FDA’s Breakthrough Device designation for its guided radiotherapy for treating lung tumors.

Biology-guided radiotherapy can detect and then treat moving tumors. The technology, which is not given a brand name in the company’s announcement of the breakthrough designation, uses injected radiotracers to produce signals from each tumor to guide treatment delivery.

Several recent lung cancer clinical trials combining radiotherapy with drug therapy demonstrate significant improvements in overall and progression-free survival, the Hayward, Calif.-based company said.