How Cutting Edge Technology Is Changing Risk Management In the EU

 

Cybersecurity, sustainability and regulatory intelligence all need factoring into risk management today as AI and data availability change the goalposts. Eight experts tell Medtech Insight how compliance efforts must adapt.

Get A Grip On Healthcare And Tariffs German Medtechs Tell Incoming Coalition

 
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The IVD industry’s new 10-point plan for healthcare change shows that medtechs will keep calling the German government to account. Tariffs, sector resilience, digital functionality are among the pressing issues industry wants answers to.

EU Commissioner: Medtech Regulations Assessment To Wrap Up by End 2025

 

Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.

Rapid Action Required For Medtech Compliance With EU Batteries Regulation

 

As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.


Owlstone Medical Develops P.aeruginosa Breath Test For Cystic Fibrosis Patients

 

Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.

Urine Test Could Halve Number Of CT Scans For Patients With Kidney Cancer

 

The urine-based GAGome test showed promise in the first clinical results from the international AURORAX-0087A, in the largest study conducted on clear cell renal cell carcinoma, the most common type of kidney cancer.

European Medicine Agency’s CHMP Qualifies First AI Tool For Use In Clinical Trials

 

With the support of AIM-MASH AI Assist only one pathologist is needed to reliably make a histology assessment of inflammatory liver disease to decide whether patients should be included in MASH clinical trials.

Barcelona’s S2 Xpeed Accelerates Hardware-Based Medtech Start-Ups From Prototype To Market

 
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Barcelona-based accelerator S2 Xpeed is driving the rapid growth of medtech and hardware start-ups in Europe. Operating under a "sweat equity" model, the program helps early-stage companies move from prototype to manufacturing readiness in exchange for equity. This month, the accelerator will add a fourth cohort of 10 more start-ups, five of which are in the medtech space.


Urgent Call for Leadership In EU Medtech To Steer Through Regulatory Challenges

 

EU medtech trade associations present detailed arguments for the European Commission’s 'targeted evaluation' of medtech regulations, highlighting the need for immediate course correction.

German Medtechs Up The Stakes On Amending Hospital Reform Law

 
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Whoever is handed the health portfolio in Germany’s new coalition government will face demands to amend the recently-enacted hospital and DRGs reform law. The medtech industry has been quick to make the case for change.

Wired Health: Women Of Wearables Shares Market Outlook

 

Medtech Insight sat down with Anja Streicher, chief marketing officer at Women of Wearables, a global community offering events and education resources to support the femtech industry, to discuss trends in the women's wearables tech market, challenges and innovators pushing the boundaries.

Medtech Regulatory System, IDAP And CERSI Top UK MHRA Agenda In March Update

 
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Britain’s medtech system progress, smarter ways of working at the agency and getting smarter AI and digital technologies into circulation for patients, were themes woven through the UK MHRA board’s 18 March meeting.


Wired Health: One-Size-Fits-All Wearables Don’t Work For Women’s Health

 

Wearable technology must address women’s unique needs, said Anja Streicher, Women of Wearables chief marketing officer. Samphire Neuroscience and Amira Health demo wearable solutions for PMS and hot flashes at Wired Health.

US FDA Teleconferences In As IMDRF Gathers In Tokyo

 
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The International Medical Device Regulators Forum discussed AI regulation, the development of a reliance playbook, and post-market regulation at the group's annual meeting in Tokyo last week. While the US FDA was not on-site, the agency was able to participate virtually.

How The European Health Data Space Is Game-Changer For Digital Device Assessment

 

The EHDS’ pivotal role in generating real-world evidence and capturing patient-reported outcomes will be a bonus for health technology assessment, especially in digital health.

NHS England Abolition Fits UK Drive To Balance Regulation With Innovation

 
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Centralized decisions and cost savings are targeted in the UK government’s plan to combine much of NHS England with the Department of Health and Social Care. The action will likely divert resources away from health ministry efforts to launch the 10-Year Care Plan, but how else will medtechs be impacted?


Careology And Entia Partner To ‘Enhance’ Remote Monitoring For Patients With Cancer

 

Careology and Entia are partnering to “alleviate the burden of routine patient assessments” on people with cancer. The two early-stage London-based health tech startups already provide services to UK National Health Service (NHS) patients.

EU Pushes Faster Route For Innovative And Orphan Devices

 

Existing legislation already offers a route, albeit rarely used, for orphan and innovative devices to reach the market more quickly. It should be used more; manufacturers and notified bodies do not need to wait for official changes to the EU’s medtech regulations.

Industry Gives Broad Welcome To Abolition Of NHS England But Needs Time To Weigh Impact

 
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Insight into the knock-on effects on innovation adoption and procurement is keenly awaited by medtechs.

Neuromod Raises $10.9M To Grow US Reach And Further Real-World Evidence

 

Dublin-based Neuromod has closed a €10m ($10.9m) series B funding round to bring a "new standard of care" to patients with tinnitus.