Validating digital endpoints in registries for regulatory acceptance is no longer a futuristic aspiration. With the FDA’s...
real-world data
In 2026, a pre-revenue digital therapeutics startup often finds itself in a bind: payers, clinicians, and investors...
The large, placebo-controlled trial is no longer the default for digital therapeutics. As DTx evidence generation enters...
Ambient Light Patterns from Smartphones as Digital Biomarkers for Seasonal Affective Disorder: Toward Real‑World Diagnosis and Treatment...
The challenge of algorithmic drift in deployed Software as a Medical Device (SaMD) demands robust post-market trial...
The promise of synthetic control arms powered by SaMD (software as a medical device) is reshaping clinical...