In an effort to streamline AI rules for high-risk systems and improve competitiveness, two European Parliament committees agreed amendments to the EU AI Act that will allow medtech companies to avoid double certification with notified bodies. A plenary vote takes place in late March.
Numares Health bets on a metabolomics-based urine test to help doctors detect kidney transplantation rejection earlier than current biomarkers, which would allow doctors to intervene earlier in trying to save the transplanted organ.
Certain short-term EU market improvement measures are expected to be in place this month, said the European Commission, which has challenged device industry stakeholders for input and advice as the EU’s late-2025 bundle of device regulatory improvements begins to take shape.
The public consultation on the European Commission’s proposed revision of the MDR and IVDR has been extended to accommodate late delivery of translated texts. EU notified bodies’ group TEAM-NB says the proposals need more balance to ensure the resulting regulations do not do more harm than good.
Vitestro raised an oversubscribed $70M Series B to scale its autonomous blood-drawing system across the Netherlands and expand into Europe. The CE-marked robot has been tested in more than 10,000 patients, and the company is pursuing FDA clearance to enter the US market.
Regulatory uncertainty has affected business planning and funding opportunities for UK medtech companies, says Gerard Hanratty, head of health and life sciences at UK and Ireland law firm Browne Jacobson. On the other hand, the UK industry should not squander the opportunities it uniquely faces.
Petra Zoellner, regulatory affairs director at MedTech Europe, provides an update on the pace and direction of travel of recent European Commission proposals and actions for the EU medtech sector, while emphasizing the need for speed.
The latest annual UK ABHI survey of medtech industry sentiment on market access, regulatory hurdles and pathways for innovation reveals polarized views and levels of frustration among manufacturers who face ever higher compliance workloads.
Germany’s updated digital healthcare “manifesto” document reflects the need to dovetail with EU’s EHDS and factor in advances in AI, and provide for a new system of primary care. The medtech industry calls for faster assessments of AI-enabled technology and better access to telemonitoring tools.
The Horizon Europe-led public-private Innovative Health Initiative has opened its funding round 12 with a call for consortia participation in five streams of research. €1bn of IHI’s €2.4bn multi-year budget is from industry members. The new SEISMIC brain surgery project has received its IHI funding.
With EU MDR/IVDR review proposals out, UK MHRA progress on a premarket regulation and, up ahead, a prospective consultation on accepting the CE marking indefinitely, now is a good time to assess EU-UK regulatory positions for the benefit of UK industry, says ABHI director Steve Lee.
The US FDA has published its annual international harmonization assessment for fiscal 2025, which reports on the device center’s progress in aligning medical device regulations with global standards to improve patient access to safe, innovative technologies.
Medtech Insight was invited to moderate a panel discussion with leading experts in neuroscience and AI during INBRAIN’s five-year anniversary in Barcelona, Spain. Panelists discussed the promises, perils in BCI development, neuroethics and outlook.
Cardiovascular disease is moving to the top of the EU’s health agenda with the release of the Safe Hearts Plan, European Parliament scrutiny of which is expected at the end of Q1. Medical device companies applaud the initiative but will seek more input as the plan evolves.
If medtech regulation is to work for patients, industry and society, Europe must move from political positioning to evidence-driven policymaking. It is time to avoid repeating the self-destructive cycle.
AI promises to be the much-needed solution to the now overly complex field of EU medtech regulatory affairs. Will every stakeholder start using solutions such as Raiana?
EIT Health has helped 3,000 start-ups and SMEs scale across Europe and supported over 120 innovations to launch. Inspired by the US MIT, the EIT Health program is on a mission to raise awareness of its value to healthtech innovators as it embarks on new methods of funding its own activities.
The European Commission’s proposal does not envisage a single centralized medtech agency, but instead sets out a targeted redistribution of tasks that could strengthen the existing framework. Professor Tom Melvin told Medtech Insight how.
Abbott’s newly CE-marked TactiFlex Duo dual-ablation catheter used for treating AFib is competing against products already introduced by Boston Scientific, J&J and Medtronic.
Seven new healthcare laws will be started in Germany 2026, and seven already underway – including the revamped KHAG hospital and DRGs reform law – will be completed. So goes the ministerial promise early in the new year. Medtechs signal further references to the so-far useful government dialog.