ARTICLE SUMMARY:
US and European policymakers work to fit rapidly advancing AI and digital tools into established device regulatory frameworks; Boston Scientific's quest for widespread reimbursement of its Intracept chronic low back pain technology; Josh Makower on how to cope with FDA regulatory staff shortages; the EC's recent proposal to revise MDR and IVDR; negotations continue for MDUFA VI; and FDA launches Quality Management System Regulation.
