Sponsorships and Speaking Engagements

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

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

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