Evidencio

Evidencio manufactures clinical decision support tools and risk assessment calculators designed to aid healthcare professionals in patient care. These include validated prediction algorithms for conditions like pulmonary embolism (e.g., Wells’ Criteria), heart failure (e.g., AHA GWTG-HF Risk Score), stroke (e.g., CHA2DS2-VASC), and cardiovascular disease (e.g., ASCVD Risk Estimator). The company also develops proprietary tools like bleeding risk scores and mortality risk estimators, all of which are software-based and intended for integration into clinical workflows.

Evidencio is based in the Netherlands. Its primary focus is on creating an open library of medical prediction algorithms, enabling healthcare providers to use, develop, or validate tools for patient-specific decision support. The company specializes in software-based solutions that incorporate validated clinical scoring systems and proprietary risk assessment models to improve clinical outcomes.

Evidencio’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry tracks information about devices authorized within the EU, including their classification and regulatory status. Listing in EUDAMED ensures transparency and compliance with EU medical device regulations.

Evidencio’s devices are classified as either Class I or Class IIa medical devices under EU regulations. The classification depends on factors like the intended purpose, risk level, and potential impact on patient safety. For example, risk assessment calculators like the CHA2DS2-VASC Stroke Risk Calculator or the TIMI Risk Index are typically classified as Class IIa due to their role in influencing clinical decisions, while simpler tools may fall under Class I. Classification determines the regulatory requirements for authorization and post-market surveillance.

Evidencio’s approach centers on providing an open platform for medical prediction algorithms, allowing healthcare providers to access, customize, or develop their own tools. Unlike traditional vendors that offer proprietary solutions, Evidencio’s library includes both widely recognized scoring systems (e.g., MELD 1.0, Wells’ Criteria) and proprietary risk estimators (e.g., ORBIT Bleeding Risk Score). This flexibility supports evidence-based, patient-tailored decision-making while adhering to regulatory standards for software-based medical devices.