How to Measure Performance for AI-Enabled Medical Devices? FDA Seeks Public Input
On September 30, 2025, the U.S. Food and Drug Administration (FDA ) posted a Request for Public Comment regarding how to measure the performance of medical devices enabled with artificial intelligence (AI). The...
Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul
The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay...
Abbott to Expand Its Cancer Diagnostic Segment
Abbott recently announced that it agreed to acquire Exact Sciences for approximately $21 billion to enter the fast-growing cancer diagnostic segment. Under the terms of the agreement, Abbott will acquire all outstanding shares of...
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