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.
EU medtech trade associations present detailed arguments for the European Commission’s 'targeted evaluation' of medtech regulations, highlighting the need for immediate course correction.
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.
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.
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.
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.
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.
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.
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 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.
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.
Insight into the knock-on effects on innovation adoption and procurement is keenly awaited by medtechs.
Dublin-based Neuromod has closed a €10m ($10.9m) series B funding round to bring a "new standard of care" to patients with tinnitus.
If medtech becomes embroiled in the EU-US trade war, access to critical and innovative medical devices will be under threat.
The European Commission has published a 44-page EHDS Q&A while industry has issued a joint paper emphasizing the importance of a stakeholder forum just as the EHDS Regulation is published and is due to enter into force.
Most fees and fee uplifts proposed by the UK MHRA to begin in April 2025 will be implemented on schedule. A general 8.85% increase will be applied to all statutory fees, but the new medical devices registration fee is subject to ongoing review and/or alternative options.
Germany’s Union parties may have little alternative than to bring the SPD into a new four-year coalition, says Clifford Chance partner and life sciences legal expert Gunnar Sachs. Health policy will likely see both textural and structural changes.
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.
Lawrence Tallon will succeed June Raine as MHRA chief executive on 1 April. UK medtechs will prioritize an early meeting with the man who since 2020 has served as deputy chief executive of Guy’s and St Thomas' NHS Trust.
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.