FDA Warns of Cyber Risks in Guidance for AI-Enabled Devices
New Non-Binding Recommendations Target Medical Device Makers, Software Developers
Manufacturers are eager to incorporate AI into a wide range of medical devices, from cardiac monitors that can spot developing heart problems to medical imaging systems that can find malignancies a radiologist might miss. The FDA released a new guidance this week on how to secure these devices.
Manufacturers are eager to incorporate AI into a wide range of medical devices, from cardiac monitors that can spot developing heart problems to medical imaging systems that can find malignancies a radiologist might miss. The FDA released a new guidance this week on how to secure these devices.