Following the late April 2025 update, GENinCode has provided a second update on the company’s interactions with the FDA with regard to its De Novo application for CARDIO inCode. Following a Supervisory Review with the FDA, held at the request of the company, the agency informed GENinCode that, while the number of outstanding deficiencies had reduced, there remained certain outstanding elements that required attention. These elements included information in relation to clinical validation. Clearl ....
