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 is designed to assist physicians at detecting findings on chest X-rays that are suggestive … Continued
HITRUST Risk-based Certification validates Imagen’s commitment to providing robust cybersecurity and in meeting key regulations to protect sensitive data NEW YORK, August 29, 2023 — Imagen Technologies, a frontline diagnostic imaging company with the first Diagnostics as a Service (DaaS) platform, today announced that Imagen’s Care Delivery Services have earned certified status by HITRUST for … Continued
Imagen developed an AI software, trained using deep learning, to assist physicians in interpreting chest X-rays. The study found that when aided by this AI system, physicians—especially non-radiologists—showed significant improvements in accuracy, becoming as accurate as radiologists, and were also faster at their interpretations.
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 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.
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’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.