Digital health, artificial intelligence (AI), machine learning and more — these concepts continue to generate buzz in the medtech world.
Last month, the FDA published guidance on clinical decision support (CDS) software. It helped to clear up what constitutes a medical device and what doesn’t. Early last year, the agency published a predetermined change control plan (PCCP) to help build a regulatory structure for such technology.
These topics and more spurred intriguing commentary on a panel at AdvaMed’s MedTech Conference in Boston today.
The panel featured viewpoints across all angles of the space. Dr. Yuri Maricich, CMO and head of development at Pear Therapeutics, offered thoughts from the developer of digital therapeutics. Brendan O’Leary, acting director of the Digital Health Center of Excellence at the FDA, provided the regulatory vantage point.
Cybil Roehrenbeck, a partner at Hogan Lovells, offered thoughts from the reimbursement side. Cassie Scherer, senior director of digital health policy and regulatory strategy at Medtronic, provided an industry perspective. Diane Johnson, senior director, strategic regulatory, MD&D at Johnson & Johnson, moderated the panel.
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