News & insights

WHAT’S CHANGING IN MEDICAL RISK

A weekly digest of regulation, patient safety, claims, medical device and cyber news for UK medical professionals and healthcare businesses. Updated every Monday.

25 September 2026 · NHS England

NHS orders immediate suspension for suspected patient-record snooping

NHS England has asked every trust to act immediately when staff are suspected of accessing patient records without proper justification. Under the zero-tolerance crackdown, suspected staff will face immediate suspension and have their access to NHS computer systems cut off.

FDA clears Marani Health’s remote maternal monitoring system

The FDA has cleared Marani Health’s M•wrap system for monitoring foetal and maternal heart signals. The system is intended to offer patients at-home monitoring rather than travelling to a clinic.

NHS England seeks staff views on maternity and neonatal care

NHS England has launched an NHS-wide conversation inviting staff to share views on improving maternity and neonatal services. Responses will inform the National Maternity and Neonatal Taskforce’s action plan.

Revvity launches kit targeting early type 1 diabetes screening

Revvity has launched the GSP T1D 3plex kit. It aims to support population screening programmes for children at risk of developing type 1 diabetes months or years before symptoms emerge.

FDA grants breakthrough designation to infant insulin dosing algorithm

The US FDA has granted breakthrough device designation to Glytec’s proposed Glucommander Pediatrics insulin dosing recommendation algorithm. It is intended for hospitalised newborns and infants under two years old.

NHS pilots rapid genomic testing for brain tumour diagnosis

The NHS has launched a major pilot of a rapid genomic test for patients with suspected brain tumours, extending it across specialist centres in England. NHS England says the pilot will deliver definitive diagnoses in days rather than weeks, potentially benefiting thousands of patients.

Australia investigates OpenAI Medicare breach

Australia has started an investigation into an OpenAI Medicare breach. Amid the probe, experts have highlighted the importance of robust AI governance when deploying the technology in high-risk contexts.

Five commissioners appointed to Commission on Human Medicines

Five new commissioners have been appointed to the Commission on Human Medicines. The commission provides independent expert advice to ministers on the safety, quality and efficacy of medicines.

Wales seeks innovations for appointments and bowel screening

Innovation challenges have opened across Wales under the Contracts for Innovation Cymru programme. They seek solutions to reduce missed appointments, improve access to planned care and modernise bowel screening pathways.

Sentencing follows fraud convictions over falsely certified medical devices

The MHRA has welcomed sentencing following fraud convictions relating to falsely certified medical devices. The case arose from a long-running enforcement investigation.

FDA panel backs Galleri multi-cancer detection test

An FDA panel has endorsed GRAIL’s Galleri multi-cancer early detection test. The panel voted 7–2 that the test’s benefits outweigh its risks.

Meropenem leaflet errors prompt Class 4 medicines defect notification

B. Braun Melsungen AG has notified the MHRA of errors in the patient information leaflet included in some batches of Meropenem 1000 mg powder and solvent for solution for infusion. The MHRA has issued a Class 4 Medicines Defect Notification, reference EL(26)A/39.

MHRA publishes September field safety notices

The MHRA has published a list of Field Safety Notices. The list covers 14 to 18 September 2026.

Summaries for general information only — not legal, clinical or insurance advice. Always refer to the original source.