On May 16, 2025, the FDA announced that it had approved for marketing an in-vitro diagnostic (IVD) device that tests blood to aid in diagnosing Alzheimer’s, granting it a 501 (k) clearance.
What is covered in the Full Insight:
Introduction
FDA Approval of Lumipulse Ratio
Comparative Advantages of the Blood Test
Impact on Leqembi Demand
Future Catalysts and Expectations
SUMMARY
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