AI Central PRO, Transparent-AI and Market Updates for April 17, 2024

ACR Data Science Institute’s AI Central had a busy month, adding a new product to the Transparent-AI program and 12 products to the directory.

New Transparent-AI Product  

A new product was added to our Transparent-AI program, which is designed to increase transparency in imaging AI and help end users have better informed discussions and selection criteria when making decisions about which algorithm might be most appropriate for their local target population.  

Visage Imaging Inc. joined the Transparent-AI program with their product Visage Breast Density. Visage Breast Density is a software application that assesses breast density from a mammography study and provides a density category A, B, C, or D according to the ACR BI-RADS Atlas 5th Edition to aid radiologists in the assessment of breast tissue composition. 

Transparent-AI consists of voluntarily provided data elements solicited from participating imaging AI manufacturers who currently have an FDA-cleared product in the U.S. market. Manufacturers who participate in this program will receive the Transparent-AI badge on their product listing. 

New Imaging AI Products 

Our AI Central directory has also been updated with 12 new products. This information is pulled directly from FDA 510K documents and updated by ACR staff. With this latest update, we see many newly cleared FDA products designed for chest x-rays. 

New products include:  

Spine CAMP™ (1.1) 

• Developed by: Medical Metrics, Inc. 
• Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to produce reports that contain static and/or motion metrics. Spine CAMP™ can be used to obtain metrics from sagittal plane radiographs of the lumbar and/or cervical spine and it can be used to visualize intervertebral motion via an image registration method referred to as "stabilization." The radiographic metrics can be used to characterize and assess spinal health in accordance with established guidance. For example, common clinical uses include assessing spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance. The metrics produced by Spine CAMP are intended to be used to support qualified and licensed professional healthcare practitioners in clinical decision making for skeletally mature patients of age 18 and above. 

FEops HEARTguideTM, FEops HEARTguideTM ALPACA

• Developed by: FEops nv 
• FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions. To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as: • Segmentation of cardiovascular structures • Visualization and image reconstruction techniques: 2D review, MPR • Measurement and annotation tools • Reporting tools FEops HEARTguide™ ALPACA also allows visualization of output generated by other medical device software (e.g. FEops HEARTguide™ Simulation Application cleared as K214066). The results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment. FEops HEARTguideTM ALPACA is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement. 

Overjet Caries Assist 

• Developed by: Overjet Inc. 
• Overjet Caries Assist (OCA) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment. 

TruPlan Computed Tomography (CT) Imaging Software 

• Developed by: Circle Cardiovascular Imaging Inc. 
• TruPlan enables visualization and measurement of structures of the heart and vessels for: • Pre-procedural planning and sizing for the left atrial appendage closure (LAAC) procedure • Post-procedural evaluation for the LAAC procedure To facilitate the above, TruPlan provides general functionality such as: • Segmentation of cardiovascular structures • Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR • Simulation of TEE views, ICE views, and fluoroscopic rendering • Measurement and annotation tools • Reporting tools TruPlan’s intended patient population is comprised of adult patients. 

Overjet Calculus Assist

• Developed by: Overjet Inc. 
• Overjet Calculus Assist (OCalA) is a radiological automated concurrent-read computer-assisted detection software intended to aid in the detection of interproximal calculus deposits on both bitewing and periapical radiographs. The Overjet Calculus Assist surrounds suspected calculus deposits with a bounding box. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of containing calculus deposits. The device is not intended as a replacement for a complete dentist’s review or their clinical judgment that takes into account other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists. 

Second Opinion

• Developed by: Pearl Inc. 
• Second Opinion® is a computer aided detection ("CADe”) software to identify and mark regions in relation to suspected dental findings which include Caries, Discrepancy at the margin of an existing restoration, Calculus, Periapical radiolucency, Crown (metal, including zirconia & non-metal), Filling (metal & non-metal), Root canal, Bridge and Implants. It is designed to aid dental health professionals to review bitewing and periapical radiographs of permanent teeth in patients 12 years of age or older as a second reader. 

inHEART Models 

• Developed by: inHEART, SAS 
• inHEART MODELS comprises a suite of medical imaging software modules that are intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. inHEART MODELS accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT and MR*. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the users are solely responsible for making all final patient management decisions. * inHEART Models AI software module is indicated for adults only and is designed for CT images only. CONTRAINDICATIONS: This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. 

Viz HDS, Viz Volume Plus, Viz ICH+

• Developed by: Viz.ai, Inc. 
• The Viz HDS device is intended for automatic labeling, visualization, and quantification of segmentable brain structures from a set of Non-Contrast CT (NCCT) head scans. The software is intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on NCCT images. Viz HDS provides volumes from NCCT scans acquired at a single time point. The Viz HDS software is indicated for use in the analysis of the following structures: Intracranial Hyperdensities, Lateral Ventricles and Midline Shift. The device output should be reviewed along with patient’s original images by a physician. 

CT Cardiomegaly 

• Developed by: Innolitics, LLC 
• CT Cardiomegaly is a command line software application intended to be run on its own or as part of 
   another medical device to automatically calculate linear and area based cardiothoracic ratio (CTR) from a CT image containing the heart. CT Cardiomegaly is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR from an axial CT slice containing the heart using a non-adaptive machine learning algorithm. Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services. The system is suitable for adults and transitional adolescents (18 to 21 years old but treated as an adult). Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of any disease. 
  

HealthFLD

• Developed by: Nanox 
• The HealthFLD device is an image processing software that provides quantitative and qualitative analysis of the liver from CT images to support clinicians in the evaluation and assessment of Fatty Liver. The HealthFLD software provides measurements of liver attenuation (mean HU in a region of interest). HealthFLD is indicated for use in non-contrast and contrast CT scans, with any clinical indication, for patients aged 18 up to 75. CTs must include a significant part of the liver. The HealthFLD device is not intended to provide a diagnosis or risk assessment of fatty liver disease. 

Overjet Charting Assist

• Developed by: Overjet 
• Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments: implants, crowns, endodontic treatment (previous root canal treatment), fillings. The device is intended to assist dental professionals in producing dental charts based on image analysis. The Overjet Charting Assist detects these findings on bitewing (BW) and periapical (PA) images for patients with primary and/or permanent teeth (Ages 5 and above), and panoramic (Pano) radiographs for patients with only permanent teeth. The device is not intended as a replacement for a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history. 

Denti.AI Auto-Chart

• Developed by: Denti.AI Technology Inc. 
• Denti.AI Auto-Chart is a Medical Image Management and Processing System (MIMPS) device aimed to assist dental professionals (Users), comprising general dentists, dental specialists, and dental hygienists, in detecting dental structures and producing dental charting data based on the interpretation of intraoral and extraoral 2D X-Ray images. Denti.AI Auto-Chart is intended to assist in: • Detecting natural dental structures: teeth and missing teeth • Detecting dental structures added through past restorative treatment: implants, crowns, pontics, endodontic treatment, fillings • Choosing treatment options • Producing dental charts based on image analysis results as well as conditions added manually or produced by integrated CAD devices The device is aimed to be used with images from the adult population only (≥22 years old and do not have remaining primary teeth). The device is not intended as a replacement for a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history.