ARTICLE SUMMARY:
Medtech CEOs share the challenges they faced and the strategies they pursued in seeking US reimbursement for their technologies, noting the positive progress CMS has made in support of digital health and remote monitoring. That includes recent proposals to improve payment for software-as-a-service AI tools. Also inside: Caption Health details its MDR saga in getting a CE mark for its AI-enabled ultrasound software platform, and FDA anxiety builds over user fee reauthorization delays.