CAD
Excitement around CAD focused on applications in breast imaging via mammography and MRI, as well as chest CT and x-ray applications for assisting in the diagnosis of early-stage lung cancer. (Currently, only 15 percent of lung cancers are caught in the early stage, according to the American Cancer Society; the five-year survival rate for treatable forms of lung cancer detected early is 70 percent.) CAD for chest CT brought increasing interest. On both fronts, CAD continues to advance accuracy and efficiency in image interpretation. Consolidation was also in the air, as iCAD, Inc. and CADx Systems Inc. used RSNA to announce their merger.On the exhibit floor, R2 Technology - the only company with a commercially available CAD system to aid in the detection of lung nodules with chest multislice CT - showed its ImageChecker CT CAD system with OmniCAD technology, the ImageChecker CT LN-500 and LN-1000 systems. R2 also showed its ImageChecker LX, DX and DM products for mammography CAD and the first CAD on PACS.
The ImageChecker CT LN-1000, which is pending FDA approval in the U.S., has already been commercially installed in Europe and R2's CR/DR Chest CAD product is currently under development. The system is a combination of dedicated computer software and hardware, providing tools for radiologists to aid in the review of CT exams. The workstation receives CT exams and DICOM structured reports of CAD-identified areas using DICOM protocols. After review of each exam, radiologists can view screens that summarize his or her findings, and save to a local database in the workstation for later review. The system offers high sensitivity and low false marker rates per exam in lung nodule detection, R2 said.
For mammography CAD, R2 showcased its three systems based on OmniCAD technology, the ImageChecker LX, DX and DM. R2 announced the FDA clearance of the LX and DX systems at the show. The new systems complement R2's ImageChecker family of products by offering a cost-effective CAD solution to mammography sites, which conduct a lower or more moderate volume of mammograms.
The R2 ImageChecker LX and DX CAD systems are approved by the FDA for use in mammography to assist in reducing observational oversights. Clinical trials have demonstrated that use of the ImageChecker system as an adjunct to review by the radiologist could result in early detection of up to 23.4 percent of the cancers currently detected with screening mammography in those women who had a prior screening mammogram nine to 24 months earlier.
Designed for lower volume sites of up to 6,000 mammogram cases per year, the ImageChecker LX processes a case of four mammogram films in just a few minutes and multiple cases can be loaded into the processor at one time. The results of the analysis for the ImageChecker LX system can be viewed on either a CheckMate Ultra flat panel monitor or a printer. Other options include connection to a mammography reporting system, and certain features such as PeerView software, Automatic Film Marker Identification (AFMI) and SuperCheck markers, which provide enhanced CAD workflow and display features.
The LX system also has the new R2004 algorithm, which enables film-based users to either maximize CAD sensitivity or minimize false positive marks through the choice of multiple operating points, R2 said. R2 claims the lowest false positive rate in the industry at 1.44 marks per case, while R2's new algorithm offers specificity in mammography CAD of up to 37 percent specificity on normal cases. Available on all ImageChecker CAD systems, this is the first algorithm featuring multiple operating points approved by the FDA.
In addition to all the features of the LX, the DX also can accept full field digital mammography images from the GE Senographe 2000D system. With the AFMI as a standard feature and an additional display option of a motorized viewer, the DX provides an economical CAD solution for those sites with up to 10,000 mammogram cases per year.
For higher volume sites, R2 offers the high-end ImageChecker DM (Dual Mode) system for digital and film-based mammograms in a single unit with an open architecture and a vendor-neutral platform. The system is designed to transmit CAD results to multiple display units and to archive systems.
To date, more than 1,200 ImageChecker CAD systems have been shipped worldwide.
Among the 10 PACS companies displaying R2's ImageChecker CAD system results at RSNA were Agfa, Philips Medical Systems, IBM, Stentor, Merge eFilm, Cedara, Rogan Delft, Cerner, PacsCube and Sectra Medical Systems.
Deus Technologies used RSNA to highlight its RapidScreen CAD systems for chest x-ray. The RapidScreen RS-2000 is an analog, stand-alone system, while the RapidScreen-Digital, based on a DICOM-compatible platform, allows connectivity to virtually any existing workstation, according to Michael Yeh, Ph.D., Deus president and CEO. Developed in partnership with GE Medical Systems, the RS-Digital is extended to process dual-energy subtraction radiographic images. The system is the only CAD system for x-ray images to be approved by the FDA for early detection of lung cancer.
Deus also offers the RapidScreen RS-2000D. Both the RS-2000 and RS-2000D increase cancer detection by 11 percent for lung lesions 9 to 30 mm and by 24 percent for lesions 9 to 14 mm.
Deus is developing and clinically testing a DICOM conformant CT Temporal Comparison Processor to allow radiologists to automatically compare two sequential CT scans from the same patient to improve workflow by simplifying the comparison of regions of interest and the measurement of the difference. Connected to a PACS, the Temporal Comparison Processor performs image segmentation of anatomic structures, slice matching and volume matching in the background and transfers registered CT scans to diagnostic workstations for review.
Breast CAD developers iCAD and CADx will soon be one, the companies announced at RSNA. Nashua, N.H.-based iCAD will continue to trade on NASDAQ, while privately held CADx of Beavercreek, Ohio, and its parent company, Qualia, will operate independently as a subsidiary of iCAD, at least until integration plans are announced. Together, the vendors tout 300 installed systems.
CADx' 2003 and 2004 sales are projected to be exceed that of iCAD, with CADx expecting to turn a profit in the fourth quarter of 2003 and in 2004, the company said at the show. iCAD had projected a profit for 2004. CADx has 71 employees and iCAD 46 employees.
W. Scott Parr is remaining as president and CEO of the new yet-unnamed company, while Jim Corbett, CADx's executive vice president, becomes president of CADx and COO of iCAD. CADx CEO Dr. Steven Rogers becomes chief scientific officer of iCAD, and will be elected to the company's board of directors. Robert Howard, one of iCAD's founders, continues as Chairman of the Company's Board of Directors.
CADx released new Second Look Version 6.0 cancer detection software at the show. The design of the Second Look platform provides radiologists with a choice of three operating points, one with the highest sensitivity in detection of potential cancers, another with increased specificity (reducing the total number of markers the radiologist must review), and a median selection that optimizes sensitivity and specificity. Radiologists can select the operating point appropriate for their clinical environments and workflows.
Second Look Version 6.0 carries FDA-cleared claims of up to 96.2 percent overall sensitivity, and specificity as low as 1.6 False Positives (FP) per case.
iCAD also showed for the first time its iCAD IQ system, having gained FDA marketing clearance in early November. The IQ system, priced 30 to 50 percent less than currently available CAD products, is designed for women's health center and breast clinics that perform fewer than 20 mammography procedures a day. It has a price tag of $70,000. This type of facility accounts for a third to a half of the market, iCAD said. Shipments were scheduled to begin by the end of 2003.
iCAD also is offering its IQ under a fee-per-procedure pricing model under the ClickCAD program. iCAD will install its IQ systems in mammography clinics at no up-front cost, and the clinics will pay $6.50 for each CAD procedure performed.
The FDA approval also permits use of the new Fulcrum digitizer in connection with the MammoReader CAD products. This allows iCAD to offer networked CAD, so satellite mammography screening and film scanning points are networked and connected in a hub and spoke configuration using the MammoReader's central CAD database.
The companies are looking to expand their portfolios to CT and CT colon CAD over the next three years.
Confirma, Inc. struck a unique chord at RSNA, highlighting its CADstream 3.0 CAD for breast MRI system. CADstream 3.0 features more automated features to help radiologists achieve higher quality imaging studies, lower costs for their practices and better communication among physicians and patients.
CADstream 3.0, available since September, zeros in on the higher rate of contrast agent (gadolinium) uptake by malignant breast tissue, due to angiogenesis of the tumor. The system checks the MRI volume, marking areas of suspicion as well as providing enhancement curve types that have been proven in research to provide patterns among cancerous areas. Some 50 units have been installed to date.
Overall, the automation of CAD for breast MR offers the potential to cut 30 minutes from the technologist's and radiologist's day, Confirma says.
Here's how the system works: once an MR scan is performed, CADstream software takes 10 minutes to reconstruct 3D images, which then take a radiologist about 10 minutes to review. Studies can then be saved on a PACS, sent automatically to a referring physician, printed to a color printer or put on CD.
There are currently four CPT codes for breast MR image processing, including 76375 for multiplanar reformatting; 76350 for subtraction in conjunction with contrast studies; 76375-26 for physician interpretation of 3D reconstruction; and 76375-59 for independent procedure code.