NEWS
GOVERNMENT BACKS RECOMMENDATIONS OF NHS DOCTORS-LED AI COMMISSION
The UK government has confirmed it will accept all 44 recommendations made by the National Commission into the Regulation of AI in Healthcare and has set out how they will be delivered across the UK. Alongside the response, The Medicines and Healthcare products Regulatory Agency( MHRA) is opening the call for applications for the third phase of AI Airlock, its regulatory sandbox for AI-enabled medical devices, with testing themes directly informed by the commission’ s recommendations. effective and trusted AI more quickly, while maintaining robust safeguards as technologies evolve.
One of the commission’ s central conclusions was that AIenabled medical devices should be assessed and monitored throughout their working life to better understand true performance, instead of over-relying on one-time assessments.
AI Airlock Phase 3 puts this principle into practice immediately, working with developers, regulators and healthcare partners to test how AI devices can be safely monitored and managed for post-market surveillance after they are deployed, generating insights, evidence and solutions that will directly inform future MHRA guidance and policy.
The commission concluded that the current regulatory approach must evolve for AI technologies by designing a more proportionate, lifecycle-based framework.
The recent response commits the UK to developing a worldleading, agile approach to AI device regulation that supports innovation while maintaining patient safety and public trust. The reforms aim to ensure patients can benefit from safe,
RENISHAW NEURO SOLUTIONS SELECTS CODESONAR STATIC ANALYSIS FOR NEUROSURGICAL ROBOT
Renishaw Neuro Solutions Ltd selected CodeSonar,
AdaCore’ s static analysis tool, to support software development on its neuro | mate stereotactic robotic delivery platform.
The medical device manufacturer is applying CodeSonar to its motion control software.
Renishaw Neuro Solutions develops technologies for stereotactic neurosurgery, including the neuro | mate stereotactic robot and neuro | inspire surgical planning software. These systems support procedures such as deep brain stimulation, stereoelectroencephalography( SEEG) and laser interstitial thermal therapy( LITT), where reliable software performance is an important part of system safety and effectiveness.
Development of the platform’ s medical device software follows a lifecycle process aligned with IEC 62304, including verification activities appropriate to its software safety classification. Static analysis contributes to that verification effort by examining code for defect classes that are difficult to expose through functional testing alone, including memory errors, resource leaks, concurrency defects and undefined behaviour. It also supports conformance checking against the MISRA C coding standard and identifies weaknesses catalogued under CWE.
“ We work in a domain where software quality must be demonstrated, not assumed. Automated static analysis is a routine part of our engineering workflow, so extending its use to the neuro | mate platform was a straightforward decision. It gives us consistent, repeatable analysis across the codebase and supports the verification records used in design reviews and regulatory activities,” said Lee Turl, Director and General Manager, Renishaw Neuro Solutions.
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