In 2026, the conversation around EHR-linked registries for FDA label expansion has moved well beyond fitness trackers...
regulatory strategy
A digital biomarker promising to transform Parkinson’s progression tracking, sleep stage analysis, or early sepsis detection can...
Recruiting fifty patients with an ultra-rare mitochondrial disorder, a pediatric neuromuscular condition, or a one-in-a-million metabolic syndrome...
The push toward decentralized clinical trials (DCTs) has transformed how sponsors collect data, engage patients, and monitor...
Comparing FDA vs EU MDR: SaMD compliance for clinical trial software has become a scheduling exercise, not...
The era of treating clinical evaluation and cybersecurity as separate regulatory tracks for Software as a Medical...
In 2026, a Berlin‑based startup called GlycoTrack embarked on the ambitious journey of bringing a next‑generation wearable...
For founders building the next generation of evidence‑based digital therapeutics, the 2024 FDA approval pathway can feel...
Adaptive Clinical Trial Design with SaMD: AI‑Enabled Digital Biomarkers Transforming Endpoints and Slashing Timelines Adaptive clinical trial...