Search Results

The MedCognetics (CogNet) QmTRIAGE™ software is a passive notification-only, parallel-workflow software tool used by MQSA qualified interpreting physicians to prioritize patients with suspicious findings in the medical care environment. QmTRIAGE™ utilizes an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam level. QmTRIAGE™ produces an exam level output to a PACS/Workstation for flagging the suspicious study and allows for worklist prioritization. MQSA qualified interpreting physicians are responsible for reviewing each exam on a display approved for use in mammography, according to the current standard of care. The OmTRIAGE™ device is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the interpreting physician's worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis. The QmTRIAGE™ device is intended for use with complete 2D FFDM mammography exams acquired using validated FFDM systems only.

The MedCognetics (CogNet) QmTRIAGE is a non-invasive computer-assisted triage and notification software as a medical device (SaMD) that analyzes 2D FFDM screening mammograms using a machine learning algorithm and notifies a PACS/workstation of the presence of findings suspicious of cancer in a study. The passive-notification enables radiologists to prioritize their worklist and assists them in viewing prioritized studies using the standard PACS or workstation viewing software. The device aim is to aid in the prioritization and triage of radiological medical images only. It is a software tool for MQSA interpreting physicians reading mammograms and does not replace complete evaluation according to the standard of care.