Nothing went wrong with the science. What went wrong was the sentence that comes after “FDA-cleared”: who pays for it. As of late 2022, only about 10 states and a handful of plans covered its products, and just 58% of the 31,000 prescriptions written in nine months were actually filled, per Medtech Insight.
The lesson I keep coming back to: an FDA authorization de-risks the science. It does not de-risk the business. The value gate is the reimbursement decision that lands months to years later, and it is a separate bet with separate odds.