The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has selected five AI-powered medical devices for a pilot program under its AI Airlock project. Launched in May 2024, AI Airlock is a “sandbox” that lets manufacturers test their devices in a virtual environment, supervised by the MHRA. This approach helps gather evidence needed for future product approvals.
The pilot will run until April 2025, and findings will shape future guidelines for AI medical devices in the UK.
Laura Squire, a lead at the MHRA, explained:
“AI medical devices can make healthcare more accurate, save time, and improve outcomes. However, we must ensure these devices are safe and reliable throughout their use.”
The five chosen technologies aim to enhance healthcare in different ways:
- AI for COPD Patients: Lenus Stratify predicts serious outcomes, like hospital admissions, for patients with COPD.
- AI in Radiology: Philips integrates AI into radiology systems to improve reporting accuracy and workflow.
- Real-Time AI Monitoring: Newton’s Tree’s FAMOS platform helps hospitals monitor AI performance.
- AI for Cancer Care: OncoFlow personalizes treatment plans for cancer patients.
- AI for Clinicians: SmartGuideline allows doctors to quickly search national guidelines with common questions.
Lord Vallance, the UK’s science minister, highlighted the importance of this collaboration:
“AI Airlock shows how regulation can help turn ideas into products that improve lives and support the UK economy.”
The goal is to ensure these innovations reach the NHS and patients as quickly and safely as possible.
Source: digitalhealth
