Technology | Artificial Intelligence | June 20, 2019

TeraRecon Receives First-of-Kind FDA Determination for Northstar AI Results Explorer

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.

For more information: www.terarecon.com

Related Content

New Module Creates a Warped MRI Scan that Matches Real-Time Ultrasound Results (Graphic: Business Wire)

New Module Creates a Warped MRI Scan that Matches Real-Time Ultrasound Results (Graphic: Business Wire)

News | Artificial Intelligence | May 07, 2021
Building the right infrastructure today will ensure the needed tools are there tomorrow, whatever the challenge may be

Getty Images

Feature | Radiology Business | May 05, 2021 | By Tom Cheesewrite in collaboration with Ludger Philippsen
The COVID-19 pandemic came as a shock, but not a
With the growing adoption of #data #analytics in #healthcare, we are seeing more clearly that there are two sides of data
Feature | Artificial Intelligence | May 05, 2021 | By Sundararajan Mani
With the growing adoption of...
As key technological advancements become more pronounced, prolific developments are anticipated to be on the future horizon

Getty Images

Feature | Teleradiology | May 05, 2021 | By Abizer Shaikhmahmud
Teleradiology is grabbing significant eyeballs,
The promise of personalized medicine, with its potential for treatments tailored to individual patients’ genomic footprints to generate better outcomes, has long tantalized the life sciences industry

Image courtesy of HealthMyne

Feature | Information Technology | May 04, 2021 | By Rose Higgins
The promise of...