Behind the scenes, there were many conflicting, but also useful discussions, which ultimately shaped the message the European Parliament delivered to the European Commission in late October about the need for changes to the Medical Device and IVD Regulations.
IMU Biosciences joins a UK consortium of 27 academic and industry partners to undertake “immunoprofiling” of 6,000 cancer patients to assess their response to treatment.
In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia about his vision for AI in health care and other highlights from HLTH. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results.
German medtech revenue growth has slowed, profit margins are being eroded, and exporters fear harsher US market access conditions on the return to office of President-Elect Donald Trump. The week became even more momentous with news of the collapse of the German government.
New guidelines from the Medical Device Coordination Group explain the policies used by the EU in regulating ethylene oxide for device sterilization.
A step-wise process is needed to improve UK diagnostic services, says a report authored by the Institute of Biomedical Science and PA Consulting. There are implications for industry in its recommendations.
The milestones on MHRA’s in-progress medtech regulatory roadmap for Great Britain will be subject to some change in the coming months.
The Life Sciences Innovative Manufacturing Fund, set out in the UK budget last month, is live for applications. More UK medtechs would benefit if the cost threshold were scaled down, the industry argues.
The European Commission has issued a draft document setting out the potential conditions for joint HTA scientific consultations on medical devices taking place in parallel with consultations with an expert panel.
Device supply interruptions and withdrawals, now common in the EU, could threaten patient safety. Newly issued manufacturer guidance from the European Commission is intended to improve transparency and minimize disruption.
UK chancellor of the exchequer Rachel Reeves said her 2024 budget announcement would address the problem of ‘hospitals being without the equipment they need.’
European cross-country HTA collaborations have much to learn from each other to keep prices from rising unfairly, Nordic health technology assessment experts say, adding that talks on collaboration are also ongoing with HTA bodies outside the continent.
The European Parliament is making a formal appeal to the European Commission to accelerate its EU MDR revision plans.
Findings of Germany’s latest annual survey of medtech opinion and business confidence are a wake-up call for European industry and heap further criticism on the EU MDR.
The second of six implementing acts for the Health Technology Assessment Regulation has now been adopted. It deals with how the European Medicines Agency is to cooperate with the European Commission and HTA experts in Europe.
An agreement between the EU and Switzerland potentially opening the way for renewal of the MRA – enabling barrier-free cross-border medtech trade – could be concluded as early as December. More good news for Switzerland, relating to the acceptance of FDA-approved products into the country, could follow in Q1 2025.
‘Unicorn’ Startup Owkin On EU’s AI Act, Funding Needs: ‘Europe Doesn’t Want To Be Under-Competitive’
The EU Artificial Intelligence Act, the first official AI regulation globally, entered into force on 1 August 2024. Two months on, Medtech Insight sits down with AI diagnostic startup Owkin’s chief diagnostic officer Meriem Sefta, and senior vice president of public affairs and impact Yedidia Levy-Zauberman, to discuss how the company is adapting to the EU AI Act, the opportunity it presents, and what is needed next for AI deployment in the EU.
The European Parliament wants the European Commission to revise the Medical Device Regulation within 100 days. But EU member state authorities warn of the consequences of rushing matters.
The public alongside clinicians and industry experts is asked to submit ideas for reforming the NHS via a dedicated online platform ahead of the new NHS Plan in 2025.
“Flying blind” into healthcare reform was among the feisty criticisms of Germany’s proposed law on hospital care improvement during the final parliamentary plenary on 17 October. SPD health minister Karl Lauterbach has stoutly defended his reform.