DeepX Health is one of seven companies chosen for the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) AI Airlock Phase 2 programme—a world-leading regulatory sandbox for artificial intelligence as medical devices (AIaMD).
What is the AI Airlock programme:
The MHRA AI Airlock is a regulatory testing environment where AI-powered healthcare technologies work directly with UK regulators to validate safety, clinical effectiveness, and post-market surveillance approaches. Phase 2 runs through March 2026, addressing regulatory challenges for adaptive AI medical devices.
DeepX AI skin cancer detection technology:
DeepX AI is an artificial intelligence diagnostic tool that analyzes dermoscopic images of skin lesions to identify lesion types and provide clinical triage recommendations. The technology integrates into existing dermatology and primary care workflows to:
· Increase diagnostic sensitivity for melanoma and other skin cancer malignancies
· Reduce unnecessary specialist referrals
· Improve patient triage efficiency in community healthcare settings
Recognition from UK Health Innovation and Science Ministers:
Health Innovation Minister Dr Zubir Ahmed MP: “The AI airlock programme is a great example of how we can test new innovations thoroughly while still moving at pace, as we seek to deliver on our promise to shift healthcare from analogue to digital.”
UK Science Minister Lord Vallance: “The AI Airlock programme is accelerating access to potentially life-saving tools, and backing manufacturers who are leading the renewal of our NHS.”
Global deployment:
DeepX Health’s tele-dermatology platform is already cleared by the US Food and Drug Administration (FDA) and European regulators, with active deployment in the United States and multiple European markets including United Kingdom National Health Service (NHS) primary care settings and pharmacy networks.
Early detection saves lives. Let’s make skin cancer screening accessible everywhere.