ARTICLE SUMMARY:
Lightstone Ventures’ Mike Carusi was a trailblazer among investors in prioritizing reimbursement for device start-ups. He talks about the history of that effort and about the current hot-button issue in reimbursement, TCET. European medtechs face challenges in reconciling Europe’s new AI Act with MDR/IVDR requirements; EPA’s final EtO emission rule factors in industry concerns about device shortages; Communicating the value of the regulatory specialist's role to the corporate bottom line.
