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...
FDA to Hold Public Meeting on Proposed Medical Device Review Recommendations
Key Takeaway: The FDA announced a public meeting and request for comments on proposed Medical Device User Fee Amendments (MDUFA )recommendations for fiscal years 2028-2032, which would govern medical device...