RefleXion files 510(k), opens manufacturing facility

By staff writers

May 23, 2019 -- Radiation therapy equipment developer RefleXion Medical has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for its biology-guided radiotherapy (BgRT) system. The firm also opened a new 50,000-sq-ft manufacturing facility in Hayward, CA.

RefleXion debuted at ASTRO 2018 with its BgRT technology, which pairs a PET/CT scanner with a linear accelerator in a single gantry for guided radiation therapy treatments. The technology targets radiation beams at cancer based on emissions from PET radiopharmaceuticals.

RefleXion believes BgRT enables more targeted use of radiation therapy in a broader range of patients, such as those with metastatic disease who usually are not good candidates for radiation. The company announced this week that it has filed a 510(k) for the system and hopes to begin delivering units by the end of 2019.

Also this week, RefleXion opened a new 50,000-sq-ft manufacturing facility to begin producing BgRT systems, located next to existing corporate offices in Hayward. The facility includes bunkers shielded with 6 feet of concrete and steel doors as radiation shielding for when the systems are tested before shipment to customers.

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