Technology | Artificial Intelligence | June 20, 2019

Class I medical device provides physicians way to accept, reject and interact with artificial intelligence-derived radiology findings

TeraRecon Receives FDA Clearance for Northstar AI Results Explorer

June 20, 2019 — Advanced visualization and artificial intelligence (AI) technology provider TeraRecon has successfully completed a U.S. Food and Drug Administration (FDA) regulatory review of its Northstar AI Results Explorer. TeraRecon said the technology and the determination are both firsts-of-kind in the medical imaging industry. Northstar is designed to work alongside the company’s EnvoyAI interoperability platform, which includes FDA-cleared third-party content listed on its EnvoyAI Exchange marketplace.

The Northstar AI Results Explorer provides an engaging physician user experience that can be integrated into the clinical systems already used throughout the health enterprise. Now with full commercial availability, Northstar can provide physicians a way to accept, reject and interact with AI-derived findings. Through the EnvoyAI marketplace, health systems can enter into a single contractual agreement and confidently run algorithms interchangeably, with a single two-hour software installation.

EnvoyAI customers currently have access to more than 80 algorithms with 20 holding regulatory clearances in various global territories.

TeraRecon maintains stringent processes, documentation and quality systems across its design, development and business operations. The FDA has determined that the Northstar AI Results Explorer is exempt from Class II premarket notification requirements, and therefore is considered a Class I medical device alongside their existing Class I EnvoyAI platform.

TeraRecon technologies including the EnvoyAI platform, TeraRecon Northstar AI Results Explorer and its flagship iNtuition advanced visualization solution, will be on display at the Society for Imaging Informatics in Medicine (SIIM) conference, June 26-28 in Aurora, Colo.

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