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...
AI-Powered Skin Cancer Detection Device Developer Announces Commercialization Partnerships
On September 1, 2026, medical device company DermaSensor Inc. announced four new industry partnerships. DermaSensor is focused on early detection of skin cancer. DermaSensor’s website states: “The DermaSensor device is the...