ARTICLE SUMMARY:
Industry reacts to EPA's proposed restrictions on ethylene oxide use at device sterilization plants; LimFlow started building its reimbursement strategy in lock-step with building its percutaneous vascular business; MCRA's Justin Eggleton on embracing real-world evidence for premarket FDA submissions; CMS' new rules for Medicare Advantage plans; and FDA's new guidance on shifting devices from COVID-era emergency authorizations to standard marketing compliance.
