by David Cassak
This is the second of a two-part series.
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Medical Device Start-ups in Europe--The New Entrepreneurs
Device start-ups are still rare in Europe. But now a combination of factors--new venture money, more receptive public markets, and a new generation of entrepreneurs--is making device company creation less exotic.
More from Europe
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The US’ foreign trading partners are not working hard enough to secure bilateral deals, says US President Donald Trump, who will introduce new reciprocal tariffs on Aug. 7. MedTech Europe stresses that patients will suffer if medtech is not excluded from the tariffs.
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Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.
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Without change, the implementation of the MDR and IVDR could hit another wall.
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Evolution of the MHRA and its offering to medtechs continues, with the hunt for a visionary chief medical and scientific officer and release of outline plans on early access to innovative devices, building on IDAP learnings.
More from Geography
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Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.
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At an Aug. 4 public meeting on MDUFA VI, FDA officials, industry representatives, and patient advocates outlined their priorities for the next user fee agreement, highlighting goals such as improved transparency, streamlined reviews, enhanced safety measures, and greater patient involvement.
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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.