Focusing on the convergence of emergent and enabling artificial intelligence (AI) with medical technology under significant regulatory compliance, we theoretically and empirically demonstrate the influence of the alignment between technological capabilities and identity claims on entrepreneurial performance in product approval. Furthermore, we explore the contingent role of media coverage on such linkage. We develop competing hypotheses on the capability-identity linkage (alignment versus complementary views) and on the contingent role of media coverage (attention versus hype views). Our analysis of the FDA review time of 414 AI/ML-enabled medical devices by start-ups supports the positive influence of the alignment between technological capabilities and identity claims (alignment view) and the deleterious moderating influence of media coverage (hype view). Our paper offers theoretical insights into the relationship between identity claims, technological capabilities, and regulatory compliance in the pursuit of innovation in the domain of Artificial Intelligence as a Medical Device (AIaMD).