The FDA cannot grant Breakthrough Device designation unless the device demonstrates novelty and potential clinical advantage. A cursory glance at OncoGel shows it was designed for delivering chemotherapy, not radioactive isotopes — it simply cannot carry a radionuclide like Yttrium-90. RadioGel, on the other hand, is a completely unique hydrogel platform for in-tumor delivery of radiation, which is why it qualified for BDD in the first place.
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