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...
FDA Issues Discussion Paper Regarding Regulation of Generative AI-Enabled Medical Devices
Key Takeaway: The FDA’s recent discussion paper seeking feedback regarding the regulation of generative AI-enabled medical devices suggests that the FDA has focused on evaluating, monitoring, and regulating such devices...
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...
Subscribe for News and Updates
