FDA Readiness:

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