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breakthrough designation

Visual of puzzle pieces forming an image of a heart
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
Sled dogs racing toward finish

Denali rare disease drug clears safety study, reduces biomarkers

Feb 6, 2025 12:05pm
Red blood cells

Karius snares FDA breakthrough tag for infectious disease test

May 16, 2024 7:55am
blood test tube

Roche, Lilly blood test for Alzheimer's expedited at FDA

Apr 11, 2024 11:06am
Human heart with ecg graph - stock photo Rasi BhadramaniGetty Images

Anumana's Pfizer-backed AI algorithm nabs FDA breakthrough tag

Jun 22, 2023 10:29am
brain money funding

Brain implant maker Paradromics nabs $33M, FDA breakthrough tag

May 19, 2023 1:39pm

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