FDA is reviewing an AI-powered cancer detection tool for potential approval
Statements (4)
- Neutral
FDA advisers are reviewing a multicancer-detection test.
- Neutral
FDA is considering requiring generative AI medical devices to demonstrate competence similar to physicians before treating patients.
- Neutral
FDA is seeking stakeholder feedback on proposed regulatory approach to GenAI-based medical devices.
- Neutral
FDA grants 510K clearance for DeepHealth's AI breast ultrasound technology