Incoming EU health commissioner gets to grips with need for MDR review and faces demands from council ministers for centralized elements in EU devices legislation.
As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.
After raising $68m series B funding in September, Neo Medical's announced on 2 December that its entire product portfolio has secured EU MDR approval. Co-CEO and founder Vincent Lefauconnier explained the rationale to Medtech Insight.
We do not want the commission to wait for its targeted evaluation before making regulatory changes to the MDR and IVDR, medtech industry representatives tell Galway meeting. They shared their vision of what could happen next.
How a medical doctor with software development interests who is pursuing a career in medtech consultancy claims to have exposed a huge overspend on the EU’s medical device database. But is he comparing like for like?
Illumina's successful appeal to the European Court of Justice could transform life science transactions. However, the ruling has notable limitations and further jurisdictional stretch from the European Commission is expected, said Latham and Watkins lawyers at the Jefferies London Healthcare Conference.
Germany’s governing coalition may have folded, but embattled health minister Lauterbach has championed his hospital reform bill to the last. Now voted through in the upper house of parliament, the bill to reform diagnosis related groups and hospital care delivery will come into force on 1 January.
This week, the US device center announced a pilot program to speed communications about high-risk recalls; Cardinal paid $3.9B for Advanced Diabetes Supply Group and GIA Alliance; a companion diagnostic for Merck lung cancer drug Tepmetko got FDA clearance; and more.
Increased staffing would enable the commission's device unit to drive urgent regulatory changes more quickly, leading cardiologist Alan Fraser tells Galway meeting
Medtech Insight spoke with executives from Spanish medtech firm Time is Brain about their wearable device that monitors stroke victims in real time, potentially saving lives.
The EU’s health nominee may not be as controversial as the recent US one, but the candidate being grilled has proved the least popular of the commissioner nominations with MEPs
Abbott is celebrating the opening of its new manufacturing facility in Ireland for diabetes care.
A short consultation has been launched by the UK MHRA on elements of devices regulation for Great Britain that have evolved since the first consultation on UKCA marking in 2021.
The EU’s PRRC role can differ substantially according to the circumstances at individual companies. But there is a need to further understand and shape PRRC's responsibilities so there is strong consistency across the board, PRRCs and associated stakeholders heard recently in Malaga.
Far-reaching AI regulations issued in the European Union also hold implications for US firms, a recent journal article claims. Companies that sell, use, import or distribute AI devices in the EU are all affected.
Medtech engineering association shares concerns over regulations, innovation and EU competitiveness with remainder of medtech industry.
The EU medtech regulations are being targeted for change, with many amendments being critical for the sector and patients. Ireland’s Niall MacAleenan explained why tackling governance is the most critical part of this at a recent meeting in Galway.
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.