FDA Clears Fovia’s CT Lung Nodule Software

Fovia Ai Inc. has received U.S. Food and Drug Administration 510(k) clearance for F.A.S.T. aiCockpit CT Lung Nodule, an application that allows radiologists to efficiently visualize, navigate, edit and accept/reject lung nodule detection algorithm results.

F.A.S.T. aiCockpit CT Lung Nodule gives radiologists a powerful tool for reviewing AI-driven radiology findings that both accelerates case times and expedites artificial intelligence integration within the radiology landscape. This streamlined application provides optimized workflows for interacting with AI results from Chest CT Lung Nodule detection AI algorithms and is the first component of F.A.S.T. aiCockpit Universal AI Viewer, which will deliver optimized workflows for all radiology AI algorithms, further eliminating the need to launch multiple viewers.

F.A.S.T. aiCockpit CT Lung Nodule can be easily embedded in existing workflows so radiologists can quickly review, edit and decide on the relevancy and accuracy of algorithm results. Adjustments to diameter and volume measurements, editing of descriptions and locations of detected lung nodules, rejection of false positives, and examination in 2D/3D are just a few examples of the possibilities within the application. Additionally, all radiologist-approved, finalized results are automatically forwarded to the long-term archive and reporting system for automated inclusion in the radiologist report.

PACS, universal viewers, reporting systems, and AI vendors, orchestrators, and platforms can install and offer this technology within their existing products, and quickly scale their AI offering. Multiple algorithms can be included in any F.A.S.T. aiCockpit CT Lung Nodule installation, eliminating the need for companies to integrate separate AI vendors and algorithms, thereby significantly reducing integration costs. Once F.A.S.T. aiCockpit is installed, companies can immediately begin offering efficient, comprehensive AI tools resulting in faster case times, thereby increasing accuracy and expediting clinical decision-making for their radiologists.

Fovia Ai, Inc. is a subsidiary of Fovia Inc., a provider of advanced visualization and cloud-based, zero-footprint imaging SDKs, and the developer of High Definition Volume Rendering, XStream HDVR, F.A.S.T. Hybrid Rendering, F.A.S.T. Interactive Segmentation, RapidPrint, and TruRender. Fovia Ai’s flagship products, F.A.S.T. aiCockpit and F.A.S.T. AI SDK, enable radiologists and clinicians to efficiently access AI results directly within their existing workflows from any PACS, worklist, dictation software or hospital system. Complementary products in Fovia Ai’s product suite include F.A.S.T. AI Annotation, F.A.S.T. AI Validation, F.A.S.T. AI Workflows and F.A.S.T. Interactive AI, collectively providing tools to annotate, validate, modify, accept/reject, interact with and segment data. The flexible architecture of Fovia Ai’s product suite and Fovia’s 20-plus years of radiology integration experience facilitate seamless integrations with a variety of partners, platforms, processors and operating systems.