OsteoDetect is the first ever FDA-cleared software device for Radiological Computer Aided Diagnosis/Detection (CAD). It uses AI to help detect and localize distal radius fractures – the most commonly misdiagnosed musculoskeletal injury. In a clinical study, the average clinician experienced a relative reduction in misinterpretation rate of 47% when aided by the software.
Imagen AI: Democratizing Access To World-Class Imaging
Imagen’s proprietary FDA-cleared AI detection and diagnosis software is helping us to provide world-class image interpretation services directly in primary care settings.
At Imagen, AI is not an academic exercise. Our software is being used in real practices today, helping real patients. Imagen is at the forefront of the AI revolution in healthcare, putting the latest deep learning techniques into actual clinical use.
Imagen’s FDA-Cleared AI Software
Missed fractures on X-rays are the most common diagnostic errors within emergency departments. FractureDetect helps eliminate these errors by detecting hard-to-spot fractures throughout the musculoskeletal system and across multiple X-ray views. Clinicians in a clinical study showed a 45% relative reduction in missed fractures when assisted by FractureDetect.
Chest-CAD detects, categorizes, and localizes suspicious regions on chest X-rays, and was shown in a clinical study to reduce diagnostic errors by 40%. The underlying AI model was trained on a massive proprietary data set, with labels comprehensively encompassing all abnormalities that can be screened for on a chest X-ray – making this model the first-ever general abnormality detector for radiology.
Imagen’s proprietary, FDA-cleared software helps physicians detect and diagnose findings more comprehensively and document findings more automatically.
Placing Patient Safety First
At Imagen, all of our technology development is done in the service of our guiding star: improving patient outcomes and placing patient needs first. To that end, intellectual integrity and scientific rigor are at the core of everything we do. We engage actively with regulators to make sure our products are safe and effective. Imagen received the first-ever FDA clearance for Computer-Aided Detection and Diagnosis (CADe/x) software for radiology, supported by extensive clinical data.
Our FDA-cleared AI products have been validated through large-scale clinical trials. In fact, we’ve gone far above and beyond what’s required: our trials are among the largest of their kind.
Read about some of our groundbreaking, peer-reviewed research:
A Multi-Disciplinary Philosophy
Imagen is uniquely positioned as a vertically-integrated organization that both develops AI software in-house and operates it through our clinical services. We directly control the deployment and monitoring of our models, and work closely with the clinicians who are actually using them. These tight feedback loops enable us to continuously improve our machine learning techniques and observe how they work in the real world.
Our AI is developed by an interdisciplinary team including machine learning experts, clinical researchers, and physicians. We work with a wide array of healthcare practitioners, and they are intimately involved in every aspect of our development process.
Scaling The World’s Best Clinical Expertise
Our AI models are trained to incorporate the human expertise of some of the world’s best diagnosticians. We’ve partnered with top medical institutions, including several leading research hospitals, to design our devices. Through these partnerships, we’ve curated some of the industry’s largest and highest-quality medical imaging datasets.