AI Central Market Updates for September 12, 2024

ACR Data Science Institute’s AI Central has been updated with a new PRO Platform manufacturer and two new products to the directory. 

New AI Central PRO Manufacturer with Platform, Transparent-AI Products 

Aidoc Medical, Ltd. joined our AI Central PRO program this month and added their platform, Aidoc aiOS, to the directory. Aidoc aiOS helps health systems overcome the challenges of AI adoption with a single, unified medical AI platform. 

AI Central PRO allows manufacturers to add additional information to their manufacturer and product profiles on AI Central to explain how their products work in an effort to improve patient care and make it easier to learn more. This gives radiologists a better understanding of how a product can best support their patients and workflows through supplemental material about each product developed by the manufacturer.    

Aidoc Medical, Ltd. also have five products in our Transparent-AI program: BriefCase-Aortic Dissection Triage, BriefCase-Pneumothorax Triage, BriefCase-Pulmonary Embolism Triage, BriefCase-Rib Fracture Triage, and BriefCase-Intra-abdominal Free Gas Triage. 

Transparent-AI 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. The program 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 two new products. This information is pulled directly from FDA 510K documents and updated by ACR staff. With this latest update, we see newly cleared FDA products designed for pediatric x-rays, chest CTs and prostate MR images. 

New products include:  

Hyper Insight-ICH 

• Developed by: SK Inc. 
• Hyper Insight - ICH is a notification-only workflow tool for trained clinicians to identify patients' brain CT images and share them with medical specialists in parallel with standard patient care workflow. Hyper Insight - ICH uses deep learning-based Al algorithms to analyze images to find suspected intracranial hemorrhage and notifies and shares the findings to medical specialists. Identification of images with suspected intracranial hemorrhage is for notification purposes only, not diagnostic purposes. In particular, this medical device analyzes non-contrast brain CT images, and if a suspected intracranial hemorrhage is identified, it sends a notification to medical specialists, who are advised to review these images. Images may be previewed through the mobile app but are for informational purposes only and are not intended to be used for diagnostic purposes other than notifications and previews. The medical specialist who received the notification is responsible for reading the image in a diagnostic viewer. Hyper Insight - ICH is limited to the purpose of analysis of image data and should not be used as a substitute for a full patient assessment or relied upon to make or confirm a diagnosis. 

Rayvolve 

• Developed by: AZmed SAS 
• Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (≥ 2 years). Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. Study type (Anatomic Area of interest) / Radiographic Views* supported: Ankle/ AP, Lateral, Oblique Clavicle/ AP, AP Angulated View Elbow/ AP, Lateral Forearm/ AP, Lateral Hip /AP, Frog-leg lateral Humerus /AP, Lateral Knee/ AP, Lateral Pelvis /AP Shoulder/ AP, Lateral, Axillary Tibia/fibula/ AP, Lateral Wrist/ PA, Lateral, Oblique Hand / PA, Lateral, Oblique Foot/ AP, Lateral, Oblique. *Definitions of anatomic area of interest and radiographic views are consistent with the ACR-SPR-SSR Practice Parameter for the Performance of Radiography of the Extremities guideline.