This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Daysi Diaz-Diesta, PhD, DABT, Senior Toxicologist at Gradient and ISO Working Group 17 Convener, for a conversation spanning AI-enabled diagnostics, biocompatibility, cardiovascular risk prediction, and the latest FDA regulatory developments.

Daysi shares her unique perspective on biocompatibility evaluation, ISO 10993 updates, and how risk assessment is evolving beyond simple testing checklists toward a more comprehensive, science-based evaluation of medical devices throughout their entire lifecycle. The discussion also explores where artificial intelligence may fit into toxicological risk assessments and why experienced scientific judgment will remain essential.

The team reviews FDA's newest De Novo authorization for CaRi-Heart, an AI-powered software that predicts long-term cardiovascular outcomes using coronary CT imaging and clinical risk factors, along with a newly approved companion diagnostic PMA for melanoma patients, an emergency use authorization for a monkeypox diagnostic assay, and new AI-powered imaging software for breast ultrasound interpretation.

Additional topics include:

• FDA's recognition of ISO 10993-1:2025 and Sep. 9 biocompatibility town hall

• eSTAR 7.0 and the new Human Factors requirements

• AI-generated 510(k) summaries—and why Allison isn't a fan

• FDA's TEMPO Digital Health pilot expands with HypertensionOS

• AI-powered pathology receives FDA Breakthrough Device Designation

• Companion diagnostics and precision medicine

• Over-the-counter medical device resources

• CDRH's updated Patient and Caregiver Connection program

• The future of preventive medicine, reimbursement, and personalized diagnostics