TAVIPILOT Software

TAVIPILOT Software analyzes live fluoroscopy during TAVI/TAVR to detect and track the non-coronary cusp and prosthetic valve, adding real-time visual guidance for valve positioning. This review covers the software only, not the separate robotic platform.

U.S. regulatory clearance and labeled boundaries: ¹. Company-reported SAITO post-market evidence: ². European CE submission status: ³. Independent European market/regulatory context: ⁴.

In the United States, TAVIPILOT Software received FDA 510(k) clearance K243884 on July 7, 2025 as a Class II device. Its labeling makes the clinical boundary explicit: guidance is not intended to replace the cardiac surgeon's or interventional cardiologist's judgment, use is prescription-only by trained specialists, and the cleared indication includes defined patient/device constraints. In Europe, Carvolix submitted the CE-mark dossier in August 2026; authorization is still pending. AiToolMap therefore does not describe the software as CE-marked or commercially authorized in Europe.

Carvolix reports a 30-patient prospective post-marketing SAITO program with no device-related adverse events and no reported technical incidents, plus accuracy validation on a larger development/validation dataset. These results are relevant but remain company-reported evidence. The FDA clearance independently supports the labeled U.S. product status, not broad claims of superior clinical outcomes.

AiToolMap has not used TAVIPILOT in a clinical setting. The 7.7 rating is a LOW-confidence desk assessment of the documented product and regulatory surface, not a claim about patient-outcome efficacy.