Hologic Inc.’s (NASDAQ:HOLX) long wait to launch its 3D breast exam system is close to over.
The company received an “approvable letter” from the Food & Drug Administration for its Selenia Dimensions 3-D digital mammography tomosynthesis system. The letter indicates that the final approval of the device maker’s pre-market approval application for the breast exam tool is only subject to a “satisfactory review and inspection of [the company’s] manufacturing facility, methods and controls,” Hologic said.
Bedford, Massachusetts-based company said it plans to work closely with the FDA to complete the final step.
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Hologic’s Selenia system incorporates 3-D imaging with 2-D imaging for breast exams to give radiologists a clearer image with more data. The device’s tomosynthesis technology produces 3-D images by digitally combining multiple X-rays, alleviating the issues associated with distortion by tissue shadowing or density, according to the company.
In September, the Selenia Dimensions system won unanimous favorable votes from the the agency’s Radiological Devices Panel on effectiveness and safety and that the benefits of the system’s technology outweigh its risks. Hologic has been waiting for approval of its the system since it submitted its PMA application in 2008. The Selenia won European certification in June.
Hologic this month reported fourth quarter results and saw significant revenue gains, but a write-down related to its MammoSite products hit its bottom line hard. The first Selenia systems sold for tomosynthesis would arrive at U.S. sites before the insurance companies have decided how to reimburse for its use, but the Selenia has the advantage in that it can be used just for 2-D while Hologic waits for the final reimbursement call on 3-D screening.
The company also announced today that it entered into an exclusive agreement with SuperSonic Imagine S.A., a diagnostic ultrasound technology developer. Under the terms of the agreement, Hologic will sell, install and service the Aix-en-Provence, France-based company’s Aixplorer ultrasound platform to its U.S. customers.
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“Hologic is committed to providing the highest quality imaging products to assist in the diagnosis of breast disease,” said Hologic senior vice president of breast health Peter Soltani. “Partnering with SuperSonic Imagine to market the Aixplorer breast ultrasound platform is a natural extension of our portfolio. With the addition of the Aixplorer system, we can provide clinicians another leading edge technology to help detect breast cancer in its early stages.”
HOLX shares closed today at $16.44, up 45 cents or 2.8 percent.
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.
