3Aware provides a real-world evidence analytics platform for MedTech companies, automating the extraction and analysis of data from EHRs and other health systems. This enables efficient post-market surveillance, regulatory compliance, and product value demonstration through actionable, device-specific insights.
Funding
$2.4M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Medical device companies face challenges in efficiently gathering and analyzing real-world evidence (RWE) to meet evolving regulatory requirements and demonstrate product value. Traditional methods for post-market surveillance and clinical follow-up are often time-consuming, resource-intensive, and may not fully leverage the depth of available electronic health record (EHR) data. This can impede market access, complicate regulatory compliance, and slow down product development cycles.
Solution
3Aware provides a specialized real-world evidence analytics platform designed to transform clinical data into actionable insights for the MedTech industry. Leveraging its proprietary aiSurveillance technology, the platform automates the extraction and analysis of data from EHRs, supply chain systems, and other health system data sources. This enables MedTech companies to conduct post-market clinical follow-up, support label expansion, and validate marketing assertions with robust, regulatory-grade evidence. By streamlining data analysis and providing clear patient-level outcomes, 3Aware accelerates study timelines, reduces operational risk, and supports informed product development and compliance efforts.
Target Audience
The primary customers are medical device manufacturers and MedTech companies seeking to enhance their post-market surveillance, regulatory compliance, and product development strategies through the use of real-world evidence.
Features
- **aiSurveillance Technology**: Utilizes advanced algorithms and AI-optimized protocols to process and analyze vast amounts of real-world patient data from EHRs, including unstructured clinical notes.
- **Device-Specific Cohort Identification**: Connects specific medical devices (via UDI, version/model number, or catalog number) to patient events and outcomes using integrated health system data.
- **Longitudinal Data Analysis**: Aggregates comprehensive longitudinal data, including Patient Reported Outcome Measures (PROMs), EHR imaging, and procedure-specific clinical evidence, for ongoing surveillance and portfolio optimization.
- **Scientific Workbench**: Features a toolset incorporating Reinforced Learning from Human Feedback, Natural Language Processing & Understanding (NLP/U), and planned End-Point Specific LLMs to streamline complex data analysis.
- **Regulatory Compliance Support**: Generates regulation-grade RWE to address EU MDR and FDA compliance demands, aiming to reduce submission time and cost.
- **HITRUST® Certified Platform**: Operates on a HITRUST® Risk-based, 2-year certified platform with robust cybersecurity measures, including continuous vulnerability scanning and annual third-party audits.
- **Data De-identification and Encryption**: Ensures data privacy through de-identification according to expert determination standards and encryption of data in transmission and at rest.
- **Scalable Data Coverage**: Provides access to data from over 60,000 devices across a patient population exceeding 20 million, sourced from diverse health system data streams.