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# FDA Clears BioProtect Balloon Implant
- URL: https://www.fdaweb.com/fda-clears-bioprotect-balloon-implant/
- Published: 2023-08-28T12:00:00.000Z
- Updated: 2026-09-14T18:53:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155190

FDA has cleared a BioProtect 510(k) for its BioProtect Balloon Implant System, a next-generation spacer designed to provide protection to the rectum during prostate cancer radiation therapy. “We believe that our balloon has the potential to revolutionize rectal protection from toxicity during prostate cancer radiation therapy,” the company says. “Not only does it provide better protection to healthy organs, it also supports dose escalation and hypofractionation, which are leading trends in prostate cancer radiation therapy.”