MedTech Dive December 7, 2021
FDA has granted another set of regulatory privileges under its breakthrough devices program. The latest batch is led by breakthrough designations for treatments of lung cancer and bone metastases that are in development at RefleXion Medical and Zetagen Therapeutics.
RefleXion is developing the lung cancer product, a biology-guided radiotherapy (BgRT) system that uses PET imaging data to track the location of tumors. By detecting positron emissions in real time and synchronizing the data with the linear accelerator, BgRT could enable physicians to detect and then treat moving tumors.
“Lung tumors are often fast moving, and a patient may have multiple tumors at the time of diagnosis, which limits the use of standard radiation techniques in the lungs,” Terence Williams,...
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