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...
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...