The EU Regulation on harmonized rules on fair access to and use of data (“EU Data Act”)[1] entered into force on January 11, 2024. The EU Data Act introduces new rules regarding the access, use and sharing of data generated by connected products, or related services. The Data Act will have an important impact on companies globally and notably on medical...

Press Release: MTI Staff was not involved in writing this content NEW YORK, June 11, 2024 /PRNewswire/ — Pager Health℠ (formerly Pager Inc.) today announced the launch of an innovative, new agent-to-agent functionality that allows all care team members, from coordinators and nurses to primary care physicians and specialists, to deliver faster and...

The integration of Real-World Evidence (RWE) in MedTech is reshaping post-market surveillance, offering unprecedented insights into device performance and patient safety in real-world settings. As regulatory bodies increasingly recognize the richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments,...

Medical technology is constantly pushing boundaries, and with it comes the ever-present challenge of securing reimbursement for innovative solutions. The path to widespread adoption for any new technology is paved with regulatory hurdles, coding ambiguities, and convincing payers of its value proposition. Here, we explore the striking similarities in...

In a recent webinar titled Strategies for Successful PMCF under EU MDR: Unlocking the Mystery, medical device industry experts Smridula Hariharan and Parvathi Nambiar engaged in an illuminating discussion. They explored cost-effective PMCF strategies, discussed how to adeptly address Notified Body comments, and presented real-world case studies...

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the most notable changes between the proposed rule and Final Rule, including the grandfathering provision and inclusion of more...