Medtech Seeks Inclusion In EU’s Groundbreaking Life Sciences Strategy

 

As the EU Life Sciences Strategy aims to drive innovation, the medtech sector is pushing for a pivotal role in a mission intended to embrace green and digital transitions, address regulatory obstacles and reduce dependency on external sources.

‘AI Isn’t Flying Off The Shelves In The NHS,’ Says Healthtech Startup CEO

 

Vendor exhaustion, insufficient clinical-grade evidence, and outdated risk management are some of the reasons the NHS is struggling to adopt AI. Haris Shuaib, CEO of Newton's Tree, shared his insights with the audience at the “Next Frontier of Medical AI” event held at DAC Beachcroft's London office on 23 April.

Ireland’s Medtech Keeps Calm While Trump Covets Its Healthcare Industry

 

The Republic of Ireland’s record in life sciences is impressive. Decades of investment, education and training have been major winners for the country’s successful economy. But its success is drawing unwanted attention from the US. Trump wants “to have that.”

AdvaMed Unveils Its First ‘AI Roadmap’ To Help Lawmakers Navigate Regulating The Technology Through Rocky Times

 

Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.


Update: Italy’s IMQ And Belgium’s SGS Named 15th and 16th IVDR Notified Bodies

 

Ireland’s NSAI reinstated under IVD Regulation designation list

Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

 

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

Keeping Germany’s Medtech Industry Apprised, Advised and Incentivized in Turbulent Times

 
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A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.

Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

 

“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.


Unlocking Potential: Could EU’s New Surgical Centers Drive Demand For Advanced Medtech?

 

Industry waits to see if there will be a surge in demand for orthopedic and cardiology devices as IHI’s EU Ambulatory Surgical Centers proposal awaits sign-off.

Anglonordic 25: Pictura Bio’s One-Minute Pathogen-Identifying Diagnostic Test

 

“Infectious disease should be treated in the community, not in hospitals,” Alex Batchelor, Pictura Bio CEO, told Medtech Insight at the Anglonordic Life Science Conference on 3 April in London.

Medtech Strategy Must Be Priority, German Diagnostics Firms Tell Government

 
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Germany’s incoming coalition government has reacted positively to industry’s calls for a dedicated medtech strategy to boost economic growth. Faster digitization, lower energy costs and “IVDR 2.0” are also on the in vitro diagnostic industry’s agenda.

Birmingham City University Develops New Defense Mechanism Against Cyberattacks On AI Systems

 

AI systems used in healthcare are vulnerable to adversarial cyberattacks, which are a growing concern, said Atif Azad, a professor of AI at Birmingham City University. Azad’s research group has developed a method that trains AI to become more resilient to cyber threats through the use of random image adjustments.


Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations

 

The deadline for comments is 30 June 2025

EU Harmonized Standards Continue To Trickle In Under MDR

 

Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.

Medtechs Eye German Health Minister Switch As Governing Parties Reach Coalition Agreement

 
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The architect of Germany’s hospital reform, Karl Lauterbach, will not be retained as health minister according to how the new CDU/CSU-SPD coalition government plans to spread the ministerial portfolios.

Commission Needs To Prioritize Devices Agency Above All Else

 

Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.


Pushing On An Open EU Door? Time For MHRA To Get Practical About UK’s Regulatory Ambition

 
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The UK’s “New Approach” to regulation has created a lot of noise, but what’s the end product? asks Taylor Wessing partner Alison Dennis, who says the UK medtech regulator should look afresh at the EU’s ready-made solution.

US Medtech Tariffs: How Will EU Navigate Unchartered Territory?

 

US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.

UK Treading A Tightrope On Trump’s Tariffs

 
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Medtech has not yet been spared from the Trump administration’s trade tariffs, which, for UK exporters will be 10% – half the rate applied to EU27 exporters.

Swiss Blast US Import Tariffs As Medtechs Look For Dialog To Forestall Damage To Industry

 
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Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.