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In Vitro Diagnostics
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 HTLH 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.
The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.
The European Parliament intends to send an official message to the European Commission to try and push for an early revision of the Medical Device Regulation.
Marabio Systems says the new funding will help accelerate efforts to bring a blood test to market in 2025 that will accurately determine if a mother is a carrier of antibodies that cause MARA, a subtype of autism that believe to cause more severe behavior.
The European Commission’s proposed timeframe for revising the MDR and IVDR is far too long, Parliament believes, and is resulting in increasingly outdated products in healthcare establishments around European threatening patient care.
Having 50 notified bodies under the Medical Device Regulation is a landmark achievement for the EU after a long and slow, journey to reach this point.