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