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...
$10 Million to $1: Exclusion of Damages Expert Results in Nominal Damages for Surgical Stapler Patent Infringement
REX MEDICAL, L.P. v. INTUITIVE SURGICAL, INC. Before Dyk, Prost, and Stoll. Appeal from the United States District Court for the District of Delaware. Summary: Damages testimony was excluded for failing...
The FDA Drops New Laboratory Test Regulations
Laboratory-developed tests (“LDTs”) are in vitro diagnostic (“IVDs”) products designed and used within a single clinical laboratory to perform high complexity testing. These tests can identify a wide range of issues...