In Vitro Diagnostics

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

Increased staffing would enable the commission's device unit to drive urgent regulatory changes more quickly, leading cardiologist Alan Fraser tells Galway meeting

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

Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?

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.

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.

Octave Bioscience’s CEO Doug Biehn sat down with Medtech Insight at HLTH to talk about the company’s plans for expanding their multivariate biomarker blood test for MS analysis and development of a diagnostic for Parkinson’s disease.

During Q3, biopharma merger and acquisition deal value reached $11.7bn and drew in $33.1bn in potential deal value from alliances. Device company M&A values reached $8.2bn, while in vitro diagnostics and research tools players’ M&A activity totaled $86.3m.

During Q3, biopharmas brought in an aggregate $17bn in financing and device company fundraising totaled $3bn; while in vitro diagnostic firms and research tools players raised $1.1m.