Digital health dealmaking is heating up (Endpoints)
Siemens Healthineers says it would welcome stake reduction by Siemens (Reuters)
Zimmer touts ASC opportunity with Paragon 28 purchase (MedTech Dive)
AHA joins call for Trump to exempt devices from import tariffs (MedTech Dive)
Medtronic’s Orleigh Bogle on changing the culture of surgical training (MedTech Dive)
Boston Scientific closes its year of PFA on a high note (MedTech Dive)
Illumina placed on China’s unreliable entity list (MedTech Dive)
Pulse Biosciences names new CFO, continuing string of C-suite changes (MedTech Dive)
Legal Overview Of MDR’s ‘Overly Broad And Vague Article 10a’ (MedTech Insight)
US FDA’s Absence Raises Concerns In International Standards Development (MedTech Insight)
Government, Regulatory & Legal
USDA milk testing shows different strain of H5N1 bird flu in Nevada dairy herds (STAT)
We are all complicit in the big lie of health insurance (STAT)
FDA clinical trial inclusivity guidelines will be back (STAT)
What happens when a rare disease drug seems to work, but the health care system doesn’t? (STAT)
FDA Tissue Biopsy Draft Guidance Could Boost Liquid Biopsy Adoption In Clinical Trials (MedTech Insight)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.