Occasional writing from the Basil Health team on themes at the intersection of diagnostic science, digital health, and investment. No frequency promises. Published when we have something worth saying.
FDA clearance is necessary but not sufficient for a diagnostic AI product. The real barrier is CMS reimbursement pathway and institutional adoption dynamics. We examine where the value demonstration gap sits and what early-stage companies should be building toward.
Single-modality diagnostic tools — imaging alone, genomics alone, lab values alone — are increasingly giving way to multimodal synthesis platforms. This transition creates a new set of infrastructure winners and clinical validation challenges that will define the next wave of diagnostic investment.
When a medical device company says it has a 'software moat,' the questions to ask are technical and regulatory, not just commercial. A structured diligence framework for evaluating SaMD claims, IEC 62304 compliance posture, and the gap between marketing slide and 510(k) submission.