"We had followed an FDA regulatory strategy based on a consultants’ advice, although it was quickly determined that the prescribed pathway was not feasible for FDA approval or reimbursement coverage. We were subsequently able to swiftly modify the project course per H.I.C's recommendations and are now on track to receive FDA approval much quicker, with coverage for an even larger market, all with less regulatory risks.”

Joseph Sokol
CEO, iCardio.ai