Advamed asks CMS to cover extra imaging of dense breast tissue (MedTech Dive)
lucoModicum’s Magnetohydrodynamic CGM Platform Moves Closer To The Clinic (MedTech Insight)
Government, Regulatory & Legal
Social media misinformation is scaring women about birth control (STAT)
Cover Supplemental Breast Screenings, AdvaMed Urges Medicare (MedTech Insight)
While the Orphan Battles Wage, Jazz Takes a Loss (FDA Law Blog)
Siemens Healthineers confident it can cope with Trump tariffs (MedTech Dive)
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.
The US Food and Drug Administration (FDA) issued final guidance on 13 August regarding the types and timelines for formal meetings that sponsors can request during the development of new drugs and biological products.