Certain Cumberlege Review recommendations are making their way into draft UK legislation as the government presses ahead in shaping the UK’s post-Brexit devices regulatory system.
A new UK role of patient safety commissioner, providing independent oversight and guidance on patient safety elements relating to device and pharmaceutical product use and surveillance, has been proposed for inclusion in the Medicines and Medical Devices (MMD) bill. The bill is currently going through parliament.
This was one of the recommendations to emerge from the July 2020 report on the Independent Medicines and Medical Devices...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
UK-based Biocomposites will begin selling in the UK its next-generation osteoinductive bone graft substitute, NanoBone, which came with its acquisition of Artoss GmbH in June 2023. Meanwhile, the company has purchased remaining shares in the manufacturers of SYNICEM and Subiton antibiotic bone cements and preformed antibiotic-loaded spacers.
The firm’s dual-chamber leadless pacemaker system with is expected to be a growth driver for Abbott and already has acquired approximately 30%-40% of market share from Medtronic since its approval by the US FDA in July 2023, according to GlobalData.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.
UK-based Biocomposites will begin selling in the UK its next-generation osteoinductive bone graft substitute, NanoBone, which came with its acquisition of Artoss GmbH in June 2023. Meanwhile, the company has purchased remaining shares in the manufacturers of SYNICEM and Subiton antibiotic bone cements and preformed antibiotic-loaded spacers.
The firm’s dual-chamber leadless pacemaker system with is expected to be a growth driver for Abbott and already has acquired approximately 30%-40% of market share from Medtronic since its approval by the US FDA in July 2023, according to GlobalData.
Amferia is developing an antimicrobial peptide hydrogel dressing to combat infections in acute wounds in humans and veterinary contexts. Supported by €1.2m of new venture capital financing, the company is planning pivotal clinical studies to support an FDA application later this year and CE mark submission in 2026-2027.
