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breakthrough designation
MedTech
Cordis’ sirolimus drug-coated balloon earns FDA approval
The FDA gave the green light to a first and only sirolimus drug-eluting balloon designed by Cordis to treat coronary in-stent restenosis.
Joseph Keenan
Sep 22, 2026 8:17am
Denali rare disease drug clears safety study, reduces biomarkers
Feb 6, 2025 12:05pm
Karius snares FDA breakthrough tag for infectious disease test
May 16, 2024 7:55am
Roche, Lilly blood test for Alzheimer's expedited at FDA
Apr 11, 2024 11:06am
Anumana's Pfizer-backed AI algorithm nabs FDA breakthrough tag
Jun 22, 2023 10:29am
Brain implant maker Paradromics nabs $33M, FDA breakthrough tag
May 19, 2023 1:39pm