FDA Clears AI Applications to Assist Radiologists

Posted on November 5, 2018 by Larry Sieb 

Artificial intelligence (AI) applications in radiology have been and are being developed by the established imaging companies and a host of new companies. Many of the recent FDA cleared applications have focused on the radiologist, aiding image analysis or improving workflow.

The major imaging companies both develop AI applications, often to improve scanner image acquisition and incorporate 3rd party solutions. Some companies offer a platform to host AI applications from companies that have been cleared by the FDA, either via the 510 (k) process or the De Novo process.

Applications to assist radiologists fall into three categories: workflow improvements, clinical decision support, or image interpretation. Workflow improvements include providing relevant patient summaries extracted from the EHR, ordering worklists to place the most critical preliminary findings first and volume segmentation and automatic labeling. Image interpretation provides identification of suspect lesions and nodules.

The table presents some AI Algorithms cleared by the FDA as of October 2018, many of which received clearance in 2018. 

Some companies have developed AI platforms to host AI algorithms from 3rd party developers. Envoy AI hosts a platform that hosts AI algorithms from developers that can be used to test and refine their applications. Once cleared by the FDA, the algorithms are available to providers to try out the algorithms and incorporate them into their practices.

Nuance has introduced its AI Marketplace to host machine machine learning and deep learning algorithms for image analysis, workflow optimization, clinical decision support, and other radiology applications and use cases. Vendors can host their applications and when subscribed to by providers, receive feedback to improve the applications.

Philips has developed the HealthSuite Insights platform which is available to healthcare providers to develop AI algorithms. The platform will also host 3rd party and Philips AI algorithms for test and further development.

The Siemens Healthineers Digital Ecosystem presents a variety of digital solutions, including AI algorithms in a store where users can purchase and deploy these offerings either installed locally or cloud-based. The Ecosystem includes clinical, operational, and financial solutions in healthcare delivery.

Carestream Vue Clinical Collaboration platform includes Carestream AI developments. One example is the use use of AI to triage exams identifying studies with urgent findings moving these to the top of the worklist. In addition, the platform integrates algorithms from other venders.

Agfa Healthcare has integrated AI into its Enterprise Imaging solution embedding algorithms into clinical workflows. Algorithms include Agfa developments and those from other industry vendors and care providers.

Change Healthcare has been incorporating AI Solutions from other vendors. GE incorporates other vendors algorithms in addition to developing their own. Many of GE’s AI developments have focused on improving the performance of its scanners, e.g., CT, ultrasound, and MRI.