
3Aware is a leading innovator in the MedTech industry specializing in advanced analytics and real-world evidence solutions that transform clinical data into actionable insights. Their proprietary aiSurveillance technology enhances regulatory compliance and device performance monitoring, enabling medical device companies to navigate complex regulatory environments and improve patient outcomes. The company offers a comprehensive platform that supports post-market clinical follow-up, label expansion, marketing assertions, informed product R&D, regulatory compliance, longitudinal surveillance, and safety and performance monitoring. 3Aware's solutions reduce regulatory submission time and cost by up to 60%, provide real-time safety and performance monitoring, and support continuous improvement initiatives, positioning them as a key player in the MedTech real-world evidence market.

3Aware is a leading innovator in the MedTech industry specializing in advanced analytics and real-world evidence solutions that transform clinical data into actionable insights. Their proprietary aiSurveillance technology enhances regulatory compliance and device performance monitoring, enabling medical device companies to navigate complex regulatory environments and improve patient outcomes. The company offers a comprehensive platform that supports post-market clinical follow-up, label expansion, marketing assertions, informed product R&D, regulatory compliance, longitudinal surveillance, and safety and performance monitoring. 3Aware's solutions reduce regulatory submission time and cost by up to 60%, provide real-time safety and performance monitoring, and support continuous improvement initiatives, positioning them as a key player in the MedTech real-world evidence market.
Sector: MedTech — real-world evidence & analytics
Core product: aiSurveillance platform for device-specific regulatory-grade RWE
Headquarters: Indianapolis, Indiana
Founded: 2022
Employees: 31
Regulatory compliance, post-market surveillance, label expansion, and R&D evidence generation for medical devices.
2022
Medical Technology / Health Care IT
Crunchbase records a Seed round announced on this date; publicly disclosed amount and investor names are not provided in the evidence.