FDA Readiness:

Decimal Health evaluates companies’ readiness through a six step process to becoming a digital therapeutic.

FDA Readiness

Decimal.health works with health systems, payers, digital health founders and funders, pharma and medical device firms to help them navigate the intricacies of the regulatory space.

FDA Approval Process:

These components include assessing the product design, business model, regulatory pathway and requirements needed to obtain FDA approval or clearance, evidence generation with clinical trials and real-world evidence generation to prove intervention’s efficacy, reimbursement (including coverage, coding and pricing) and finally distribution workflows to distribute through prescribing channel.

FDA Approval Process