3Aware is an aiSurveillance platform that applies artificial intelligence (ai) to patient medical records delivering a reliable, fast, and affordable way for MedTech to ensure product safety and performance and accelerate innovation.
Clinical data collection is an essential part of regulatory compliance and where 3Aware excels. While most MedTechs capture data using conventional sources such as clinical studies, 3Aware’s all-in-one aiSurveillance software platform collects safety and performance data from patient records. 3Aware takes this real-world evidence and combines three steps, or three “A’s,” needed to fulfill regulations:
Access high-quality, device-specific, safety and performance data from patient records and longitudinal information Analyze patient outcomes using ai to derive deeper insights Alert device manufacturers to events of interest resulting from unknown side effects, emergent risks, systemic off-label use or misuse, and provide notifications to drive action