Genome + CellsCasgevy (exagamglogene autotemcel)
FDA-approved Dec. 8, 2023 for sickle cell disease (age 12+); CRISPR Therapeutics reported on Aug. 3, 2026 that the FDA extended approval to children 2 years and older.
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Approved/cleared
Genome + Cells
DeepTech + MedTechda Vinci 5 surgical system — cardiac indications
FDA 510(k) clearance for certain cardiac procedures announced Jan. 26, 2026 (company release).
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AI + MedicineOptive AI software for Swoop portable MRI
Hyperfine reported FDA clearance of next-generation Optive AI software in its Q2 2026 results on Aug. 6, 2026 (company release).
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