AI-Enabled Medical Devices Require an Integrated FDA and IP Strategy
Key Takeaway: Medical device companies should prepare a cohesive patent and premarket submission strategy by considering FDA recommendations when developing AI-enabled features and coordinating statements made to the Patent Office...
Permission Granted: D.C. Circuit Preserves Medical Device Repair Access
Key Takeaway(s): Medical device companies should treat copyright as just one part of a layered protection strategy. The DMCA repair exemption preserves meaningful access for qualifying third-party diagnosis, maintenance, and...
FDA Launches Expedited IND Pilot Program to Accelerate Human Trials, Raising IP Considerations for Sponsors
Key Takeaways: The Expedited Investigational New Drug (IND) Pilot Program is intended to evaluate whether leveraging qualified research institutions (QRIs) and a rolling review process can improve the efficiency of...
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