More CAD firms reach market as prospects for adoption grow

The field is beginning to clear for computer-assisted detection (CAD). Last year, only R2 Technology was certified to market the technology in the U.S. This year, Deus Technologies¹ system got the green light for lung cancer detection, CADx received an FDA approvable letter for its mammography system, and R2 gained FDA certification for breast cancer diagnosis, as well as a thumbs-up on its system for direct use on files captured digitally.

Vendors were enthusiastic about Medicare¹s decision to initiate CAD reimbursement at $17.74, beginning in January 2002. With that payment level and new and faster technology coming in at lower price points, the use of CAD could start to spread quickly. Centers without many experienced mammographers should feel the impact of the technology the most.

CADx Medical Systems

The company is dedicated to developing CAD systems and has agreements with both Fischer Imaging and Hologic for the use of its CAD technology. Its first product, Second Look, is designed for mammography screening.

• Second Look received an approvable letter from the FDA in November. Previously, the product could be sold only outside the U.S. It uses printed reports outlining suspicious microcalcifications and masses.
  
• Second Look AD was shown as a work-in-progress. This unit supports both analog and digital CAD. The upgraded software paves the way for the use of Second Look in conjunction with digital systems.

Deus Technologies

A developer of CAD software and systems, the company has created RapidScreen RS-2000. The technology integrates proprietary digital image processing algorithms, neural networks, and fuzzy logic to detect early-stage lung cancer from chest radiographs.

• RapidScreen, which focuses on lung cancer, was cleared by the FDA in July 2001. Chest x-rays are digitized and displayed on screen, and suspicious areas are automatically circled.
  
• The work-in-progress RapidDisplay is being groomed for use in CT. The system is designed to help radiologists look at previous studies and compare regions of interest. Volumetric registration and reslicing aids comparison of studies. Current image sets are searched for suspicious areas and marked.

Fujifilm Medical Systems USA

Aside from radiological film, the company¹s strengths are in CR and PACS: CAD is more a means than an end.

• The vendor is developing CAD technology called Pattern Enhancement Processing as part of an effort to extend CR to mammography.
  
• Clinical trials under way in Japan indicate that Pattern Enhancement Processing may boost diagnostic accuracy. This is an important selling point in a nation facing a shortage of radiologists specializing in mammography.

Intelligent Systems Software (ISSI)

The company focus is on mammography. Its first product is MammoReader 2001, a CAD system designed to assist in the early detection of breast cancer.

• MammoReader digitizes and then analyzes mammography films. Reports can be printed on paper or read on a PC. Barcodes are attached to and read off each film to enhance workflow and image tracking, eliminating the need to presort films before they go through the digitizer.
  
• The goal is to come out with a relatively inexpensive system, possibly under $100,000. Clinical trials began last spring with partial funding of $1 million from the National Cancer Institute.
  
• Instrumentarium has obtained exclusive U.S. marketing rights for MammoReader, which is currently being reviewed by the FDA.

Mirada Solutions

Image analysis systems being developed by the company include image fusion packages for CT, PET/SPECT, and MR scanners; training and diagnostic tools to help clinicians interpret x-ray mammograms; and systems for analyzing and quantifying echocardiograms.

• A work-in-progress mammographic processing technology was shown. The system has potential in CAD and quality-control applications, according to the company.

R2 Technology

The company¹s ImageChecker identifies areas on mammograms that may be cancerous. Early development is focused on mammography, although R&D is under way to explore other applications, including the analysis of chest x-rays and lung CTs.

• ImageChecker has been cleared by the FDA as a stand-alone unit. The agency has not yet ruled on the use of this technology as an integral part of a full-field digital mammography system.
  
• Checkmate Ultra was demonstrated. Touching the highlighted area on the display screen causes the computer to outline and deliver information about the suspected lesion.
  
• Pulmonary CT development was highlighted as a work-in-progress. A major advantage of the software may be helping radiologists handle the large number of images produced by new multislice CT scanners.

Scanis

The company¹s Mammex TR automatically analyzes mammograms and highlights features of interest. The system is being sold in Europe but not in the U.S., pending FDA clearance.

• Version 1.4 of the Mammex TR CAD system was announced. This upgrade reduces processing time to four minutes per case. A new user interface was also shown, offering five languages and simplified, one-button control of multiple operations. The system is being reviewed by the FDA.
  
• The firm has been granted a Canadian patent for the underlying CAD technology. Patents have already been issued in Japan and the U.S