PREDISURGE

Predisurge develops AI-powered software tools specifically designed for vascular intervention planning. These include systems like PlanOp Aortic, which aids in aortic sizing, and PlanOp iSizing, which helps assess pre-procedural complication risks. The tools are intended to assist clinicians in optimizing device selection and procedural strategies for aortic interventions by providing automated measurements and predictive analytics.

Predisurge is based in France, which places its devices under the jurisdiction of the European Union’s regulatory framework. Since its products are classified as Class IIa medical devices under the EU Medical Device Regulation, they must comply with EU-wide requirements, including registration in the eudamed database. Operating from France ensures alignment with EU standards for software-as-a-medical-device solutions.

Predisurge’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registration is mandatory for Class IIa devices under the EU Medical Device Regulation, ensuring transparency and traceability of the products within the European market.

Predisurge’s devices fall under Class IIa classification according to the EU Medical Device Regulation. This classification is determined based on their intended use—AI-driven software tools for vascular intervention planning—which carries a moderate risk level. Class IIa devices require compliance with specific design controls, clinical evaluations, and post-market surveillance requirements to ensure safety and performance.