Sponsorships and Speaking Engagements | 17 May 2023 | 12:00 p.m. - 1:30 p.m. (IDT)

Biomed Israel: 2023 Regulatory outlook: Medical technology trends shaping the future

In this lunch symposium at Biomed Israel 2023, the Hogan Lovells team will provide an overview of the current EU and U.S. medical technology landscape and examine the trends shaping the future of the industry.

Due to the innovative and ever-changing landscape of the medical device technology industry, companies must be flexible and adaptable to the trends that are shaping these industries in order to be competitive. Positioning a product for success demands a firm grasp of the processes, issues, and trends in order to prepare for, as well as uncover, the risks and opportunities. The team will cover the following areas:

• Trends and challenges in medical device approvals and their review times
• MDUFA V and its effect on device review
• FDA compliance and key enforcement actions
• Digital health and AI/ML device trends at FDA
• Medicare coverage of new technologies and payment and coding for AI technologies
• Growth capital and M&A outlook
• EU MDR and IVDR regulation and data privacy
• Privacy and cybersecurity for medical devices
• U.S. data protection regulation for digital health and AI/ML