“Inequities in relation to the regulation of medical devices must be addressed more thoroughly.”
That was the reaction of the UK Medicines and Healthcare products Regulatory Agency (MHRA) on the release of an independent...
Unfair Bias In Device Design: UK MHRA And Government Promise Action
The issue gained UK momentum on use of pulse oximeters during COVID
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A 15-month UK independent review of ethnic and other biases in device design has called for treatment inequity to be addressed at the highest levels of government, more resources for the MHRA and equity assessments to be included in approvals and post market surveillance.
Keep up with the top medtech business and regulatory news.
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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.
More from Europe
• By
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.
• By
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.
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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.