In this episode you’ll discover:
Biologics, including reimbursement, accelerated FDA approval pathways, what sector of the industry can speed growth for everyone, and the push for developing mRNA and gene editing therapeutics for difficult or rare disease states;
Software as a Medical Device (SaMD) and how the new “remote therapeutic monitoring” CPT codes revealed last week in the proposed 2022 MFPS will increase reimbursement options for mood and pain management—as well as the FDA’s investment in the Digital Center for Excellence to improve the regulation of SaMD;
Decentralized trials and home digital health tools and how these trends are expanding recruiting options and returning more realistic data because people are accessing and using these products at home.