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cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC). cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC. The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. The device results should not be used alone to make any diagnosis and/or treatment decisions.

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cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC). cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC. The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection and should not be used alone to make any diagnosis and/or treatment decisions. cmAngio is for prescription use only.

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cmTriage is a passive notification for prioritization-only, parallel-workflow software tool used by radiologists to prioritize specific patients within the standard-of-care image worklist for 2D FFDM screening mammograms, cmTriage uses 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. These flags are viewed by the radiologist via their Picture Archiving and Communication System (PACS) worklist. The decision to use cmTriage codes and how to use on Triage codes is ultimately up to the radiologist. cmTriage does not send a proactive alert directly to the radiologist. Radiologists are responsible for reviewing each exam on a diagnostic viewer according to the current standard of care. cm Triage is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the radiologist's worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis. cmTriage is for prescription use only.

CureMetrix's cmTriage is a radiological computer-assisted triage and notification software device. Digital two-dimensional (2D) mammograms are captured by a Full-Field Digital Mammography (FFDM) system and deposited on the PACS. The CureMetrix image forwarding software, acting as a PACS listener, receives a copy of the mammography DICOM image(s), creates a local copy of the image(s), de-identifies the local copy, transmits the local copy, transmits the local copy to the CureMetrix cloud, and then deletes the local copy. Within the CureMetrix cloud, the cmTriage service receives the DICOM image(s), groups them by study, analyzes the image(s) within the study, and produces a result for each study. The results are produced in the form of DICOM Structured Report (SR) file with a cmTriage result. The result file is encrypted and transmitted from the CureMetrix cloud back to cmEdge where it is decrypted and reassociated with the original study. The DICOM SR is then routed to the PACS. Once the PACS receives the DICOM SR, the file is opened, the cmTriage code ("Impression Description") is extracted for the exam, and the worklist column for the exam is updated. The cmTriage code will either indicate "Suspicious" or "" (blank). Within the PACS worklist the cmTriage code can be displayed in a separate column. Each PACS may have different features and functionality depending on the manufacturer which are outside of the scope and control of CureMetrix and cmTriage. However, in general, at a minimum, the user is able to sort their worklist based on values in columns. This sorting functionality (if present) would allow the radiologist to group Suspicious exams together. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The standard of care for breast cancer screening in the US is quickly becoming one in which both FFDM and digital breast tomosynthesis (DBT) are acquired during the exam. However, cmTriage only operates on 2D images. If a site does not use FFDM and 2D but instead only uses 3D and DBT, they will not be able to use this current device. In summary, the cmTriage device is intended to provide a passive notification through the PACS to the radiologist indicating the existence of a case that may potentially benefit from that radiologist's prioritization.