When a digital health company plans a clinical trial for a new medical device, the first strategic...
real-world evidence
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...