The FHA Knowledge Hub

AI-enabled medical devices are routinely cleared by FDA, yet commercial adoption is often blocked by unclear reimbursement. CPT Appendix S provides the framework to align AI work with coding, valuation, and payer expectations.

The rollout of the Electronic Submissions Gateway Next Generation represents a broader shift toward digitally enabled, scalable, automation-ready regulatory interactions.

Under the updated Compliance Program and forthcoming QMSR, FDA is moving toward a focused, risk-based inspection model that aligns more closely with ISO 13485:2016.

On December 5, 2025, FDA unveiled the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot — a first-of-its-kind initiative to expand access to digital health technologies for chronic disease.

A reader study with 24 radiologists across 260 Digital Breast Tomosynthesis examinations — recognized among the most cited AI breast radiology articles.

Ultra-portable X-ray systems are advancing beyond traditional mobile carts to lightweight, point-of-care platforms expanding access across community clinics, home care, and remote settings.

Translating promising algorithms into regulated, clinically adopted Software as a Medical Device requires systematic alignment across regulatory, clinical, and commercial milestones.

Sample size impacts budget, feasibility, and success of IVD regulatory applications. Just as important: an unbiased study representing the intended use population.

FDA's draft guidance helps developers build safer, more transparent, and more reliable AI-enabled medical devices as AI transforms imaging, diagnostics, and clinical decision support.

The American Cancer Society National Lung Cancer Roundtable has named four advanced imaging technology areas as priorities for development. For teams building AI-enabled imaging and diagnostic products, the more immediate signal is where reimbursement is already moving.