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FDA-Approved AI Radiology Devices

April 16, 2024

There is a significant trend in radiology where AI/ML-enabled devices are not only enhancing imaging capabilities but are also setting new standards in diagnostic accuracy.

Industry Trends: In the first half of 2023, radiology had the most (79%) medical devices submitted for approval by the FDA.  

The 82 FDA-approved medical devices in 2023 within the domain of radiology that utilize AI/ML technologies cover a range of applications, including:

→ 3D Diagnostic Imaging: 8 devices

→ Contouring: 8 devices

→ Detection and Decision Making: 44 devices

→ Image Enhancement: 15 devices

→ Management: 2 devices

→ Reduced Scanning Time: 5 devices

Among noticeable companies like Seimens, Canon Medical, and many more. Leading the way here, though, is GE Healthcare with 10 FDA-approved medical devices. 

One of their notable offerings is Precision DL, a software specifically designed for image enhancement in PET/CT imaging. Time-of-flight technology in PET/CT imaging works by estimating the time difference between when two gamma photons, produced by a positron emission event, are detected. While effective, hardware-based ToF can be limited by high costs and inflexibility, Precision DL addresses these challenges through software, utilizing a deep learning approach.

It employs a convolutional neural network (CNN) that has been trained on thousands of PET images. This model learns to recognize intricate patterns and nuances in the imaging data that can enhance overall image quality. This software is designed to enhance small, low-contrast lesion detectability and overall image quality, providing key enhancements such as:

  • Up to 64% improvement in contrast-to-noise ratio
  • Up to 28% enhancement in contrast recovery
  • Settings are adjustable to low, medium, or high, allowing customization to specific clinical needs without new hardware expenditures.

Precision DL claims to match the benefits of image enhancement by hardware ToF. We believe that understanding these current implementations and their clinical validations will aid in enhancing your strategies for MRI, CT scans, and other radiology applications.

The emergence of such interesting developments in this field could signal its promising future potential. In line with this, GreyB can help discover informative insights and formulate improved decisions.

GreyB Services Pte. Ltd 1 Scotts Road #24-05, Shaw Centre Singapore Singapore

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