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Medical Device

Navigating High-Risk AI In EU Medtech: Essential Legal Tips From Experts

Are you selling a high-risk AI-enabled device or service? Understanding the next steps is crucial. A team of legal experts has shared valuable advice to help you start to understand the complexities.

Analysis: Competition Increases Amid China Medtech Market Growth

China's medical equipment industry is growing rapidly, driven by limited domestic presence in high-cost segments and increasing adoption of local products in areas like monitoring equipment, defibrillators, and ventilators. International giants dominate the high-end market, but domestic companies such as Neusoft Medical Systems and Mindray Medical are making significant strides.

China Medtech: Rapid Localization, Business Model Shift And Market Restriction

China's medical equipment industry is growing rapidly, driven by limited domestic presence in high-cost segments and increasing adoption of local products in areas like monitoring equipment, defibrillators, and ventilators. International giants dominate the high-end market, but domestic companies such as Neusoft Medical Systems and Mindray Medical are making significant strides.

Micron’s Peel & Stick Technology Offers Hope For Needle-Free Drug Administration

Steven Damon, Micron Biomedical CEO, discusses the promising future of Micron’s microneedle technology, which allows for painless vaccine delivery through pressing a small patch onto the skin.

EU Medtech Heading For Turmoil? Navigating The Impact Of US President Trump’s Orders

In the wake of a series of unprecedented executive orders from US President Trump, the EU medtech industry faces significant political, regulatory and business challenges. Swift and strategic action is essential to ensure stability and safeguard patient safety.

EU Urged To Prioritize Clinical Strategy Talks In Pre-Submission Process

EU industry advocates for amendment to existing proposal to streamline clinical strategy costs and timelines, as well as boost efficiency and innovation

New Deadlines Loom For Medtech And App Developers Under New EU AI Act

As the EU AI Act takes shape, critical details are emerging rapidly. However, the approaching deadlines are even more pressing. This article delves into the essential information that medtech professionals need to stay ahead.

A Blueprint For The Future: Germany’s Medtech Sees Chance In More Government Roundtables

Germany’s government-industry healthcare industry roundtables have yielded a final report, even though the program was curtailed by the snap election. The new CDU-led government should pick up the baton, medtech industry associations say.

Have Your Say: Should The EU Have eIFU For All Professional Use Devices?

Industry and healthcare professionals generally welcome the European Commission's proposal to broaden the use of eIFUs. However, more official statements are still awaited.

Dealmaking Quarterly Statistics, Q4 2024

During Q4, biopharma merger and acquisition deal value reached $9.4bn and drew in $72.8bn in potential deal value from alliances. Device company M&A values reached $395m, while in vitro diagnostics and research tools players’ M&A activity totaled $604m.