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Category: Medicines and Healthcare products Regulatory Agency

NHS and NICE announce plan to adopt innovative medical technologies for patients

NHS and NICE announce plan to adopt innovative medical technologies for patients
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The proposals will help MedTech developers access NHS funding to fast-track products

May 29, 2024 Department of Health and Social Care, medical technology devices, Medicines and Healthcare products Regulatory Agency, MedTech, National Institute for Health and Care Excellence, News, NHS England, Officer for Life Science

MHRA’s AI Airlock to address challenges for regulating AI medical devices

The sandbox will help to inform future AI Airlock projects and influence future AlaMD guidance

May 10, 2024 AI Airlock, AI as a Medical Device, artificial intelligence, Medicines and Healthcare products Regulatory Agency, News, regulatory sandbox

Nova’s Xromi approved in UK and EU for vaso-occlusive complications of SCD

The inherited disorder is caused by genetic mutations that affects haemoglobin production

May 2, 2024 European Commission, hydroxycarbamide, Medicines and Healthcare products Regulatory Agency, News, Nova Laboratories, sickle cell disease, Xromi

MHRA approves Marinus Pharmaceuticals’ Ztalmy for CDKL5 deficiency disorder

The rare epileptic seizure disorder currently affects around one in 42,000 people in the UK

March 8, 2024 cyclin-dependant kinase-like deficiency disorder, ganaxolone, Marigold, Marinus Pharmaceuticals, Medicines and Healthcare products Regulatory Agency, News, rare genetic disorders, Ztalmy
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