Niche Innovator Deltex Medical On Market Access, EU MDR And A Mission To Change The World

TrueVue Oesophageal Doppler Monitor Developer Guards Its Space In A Market Characterized By Multinationals

The UK market has become tougher for smaller innovators, says Andy Mears, CEO of Deltex Medical, which plans to launch a new iteration of its minimally invasive ultrasound-based technology, the oesophageal Doppler monitor. He explained how market access challenges have steepened.

OR procedure (Shutterstock)

Medtech Insight caught up with Deltex Medical CEO Andy Mears during the Medica 2024 exhibition and conference in Düsseldorf, Germany, where the UK SME was profiling its TrueVue technology and taking the opportunity to meet international distributors for current and future business expansion.

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Medtech Industry Faces Tariffs Despite Pleas for Exemption

 
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Medical devices, diagnostics, and equipment face tariffs announced by President Donald Trump, despite industry pleas for exemption. The tariffs, ranging from 10%-49%, impact most countries trading with the US, potentially hindering innovation and increasing costs in the medtech sector.

FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials

 

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.