Devices & Diagnostics

Virtual colonoscopy product wins FDA approval

Federal regulators cleared a new device for U.S. sales that produces three-dimensional images of the colon, specifically identifying polyps and other suspicious tissue that can be an early sign of cancer. Nashua, N.H.-based iCAD Inc. (NSDQ:ICAD) developed the system, called the VeraLook, and already markets similar computer-aided detection equipment for breast and prostate cancers. The […]

Federal regulators cleared a new device for U.S. sales that produces three-dimensional images of the colon, specifically identifying polyps and other suspicious tissue that can be an early sign of cancer.

Nashua, N.H.-based iCAD Inc. (NSDQ:ICAD) developed the system, called the VeraLook, and already markets similar computer-aided detection equipment for breast and prostate cancers.

The Veralook had previously been approved for sale in Europe and Canada and 510(k) clearance by the U.S. Food & Drug Administration has been quietly anticipated for some time inside the company.

Still, iCAD executives were more than happy on Wednesday to tout VeraLook’s attributes, saying it will help doctors better intepret Computed Tomography Colonoscopy images while the non-invasive nature of virtual colonoscopies is working to convince more people to get screened.

“Our technology has become an important tool in helping radiologists find colon cancers earlier and with greater confidence,” iCAD CEO Ken Ferry said in a prepared statement announcing FDA clearance. “More than 40 million individuals who are eligible for colon cancer screening do not undergo any screening at all. Virtual colonoscopy may prompt a greater number of people to have this potentially life-saving test.”

As part of its 510(k) application, iCAD submitted results from a clinical trial indicating more than two-thirds of the CAD-enabled CT colonoscopy readers were more accurate than unassisted readers. CAD-assisted colonoscopies also were 5 percent more likely to detect polyps 6 millimeters or more in size, the study found.

The VeraLook algorhithms automatically identify polyps in images produced during virtual colonoscopies. A typical exam often contains between 1,200 to 1,500 images and VeraLook can find potential polyps that may not have seen in initial reviews.

“Computer-aided detection for virtual colonoscopy will help us find more cancers at an earlier stage,” said Dr. Abraham Dachman, lead researcher for the clinical trial and a professor of radiology at the University of Chicago.

Although the company has not yet set a firm date for a U.S. launch, Veralook will likely be offered as part of third-party display workstations and from picture archiving and communication systems vendors. iCad said virtual colonoscopy currently is included under colon cancer screening guidelines developed by the American Cancer Society and in effect in 22 states and the District of Columbia.

Reimbursement for CTC screening procedures also is available from many U.S. private insurers, the company said.

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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