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New AI device expands Diagnostics as a Service platform capabilities. NEW YORK, Dec. 5, 2022 /PRNewswire/ — Imagen Technologies, Inc. announced the U.S. Food and Drug Administration’s 510(k) clearance of the computer-assisted detection (CADe) device Aorta-CAD. This new, FDA cleared device ...

Imagen’s FDA-cleared AI software, FractureDetect, designed to detect fractures in musculoskeletal radiographs, improves clinicians’ accuracy at diagnosing fractures. Clinical testing showed that both clinicians with extensive training in musculoskeletal imaging and clinicians with limited training in musculoskeletal imaging were significantly more accurate when assisted by FractureDetect.

Imagen’s FDA-cleared AI software, Chest-CAD, designed to detect suspicious regions of interest in chest radiographs, highlighted a region of a chest X-ray that was previously missed during unaided interpretation. This case shows that additional information provided by Imagen’s AI software was able to detect a life threatening finding.

Imagen developed an AI software designed to detect fractures across multiple anatomical areas throughout the musculoskeletal system. A multi-site study showed the AI software, referred to as a deep learning system, accurately identified fractures throughout the adult musculoskeletal system. The results were used in part to support FDA clearance of Imagen’s software (FractureDetect) which now assists clinicians in detecting fractures for the subset of the anatomic regions reported in this paper.

Imagen developed an AI software designed to detect and localize fractures in wrist radiographs. A rigorous clinical study showed that the clinicians utilizing the AI software, referred to as a deep learning model, had a 47% relative reduction in misinterpretations. The significant improvement in diagnosing fractures shows that information provided by Imagen’s AI software can substantially enhance physician accuracy.