Having breast surgery to remove a cancerous lump is traumatic enough. Learning that you’ll need another operation to remove cancer cells that the surgeon couldn’t detect the first time only adds to the worry — and the cost.
Australian startup OncoRes Medical won FDA breakthrough device designation in October 2020 for its handheld imaging device designed to identify residual cancer cells in breast tissue after the surgeon has removed a tumor but before concluding the procedure. The idea is to enable surgeons to remove all cancer on the first try, thus avoiding a second procedure.
The recently announced breakthrough designation enables OncoRes to work closely with the FDA to develop its imaging system in an expedited regulatory review process.