Digital therapeutics (DTx) sit at the intersection of healthcare and technology, demanding rigorous evidence to prove safety,...
real-world evidence
When a digital health company plans a clinical trial for a new medical device, the first strategic...
As the FDA moves to a Software Precertification (Pre-Cert) program in 2025, payers are increasingly looking for...
Securing FDA approval for a low-cost digital therapeutics (DTx) platform is a formidable but achievable goal. By...
In 2024 the FDA’s Real‑World Evidence (RWE) program continues to expand, offering manufacturers a new pathway to...
Securing reimbursement for a digital therapeutic in the European Union requires more than meeting the Medical Device...
When the FDA opens a new portal for real‑world evidence (RWE) submissions, companies must adapt quickly. A...
In 2026, the U.S. Food and Drug Administration (FDA) has sharpened its focus on real‑world evidence (RWE)...
In 2026, real‑world evidence (RWE) has become a cornerstone of FDA decision‑making. Researchers and sponsors must now...