Hologic Inc. landed Food & Drug Administration approval for software it says will allow radiologists to better analyze mammograms.
The Bedford-based women’s health products maker said it won regulatory approval for its R2 DigitalNow HD software, which can digitize older film-based mammograms.
Marketing director Jim Culley told MassDevice in an email that identifying a cancerous growth is difficult because of its resemblance to breast tissue. As a result, radiologists prefer to examine at a series of images taken over time to determine if there are growths inside the breast.
One problem, Culley explained, is the large number of screening sites in the U.S. that use analog photographs, which can lose image quality when they’re digitized. The R2 DigitalNow HD software would eliminate that problem, he said.
Last month the firm said it’s been mired in what it called the “ever-changing landscape of federal Food & Drug Administration personnel and regulatory requirements” for more than a year. The system, which Hologic claims can detect breast cancer much earlier than other imaging systems, is already approved for sale overseas.
The delay in landing pre-market approval in the U.S. forced Hologic to shelve plans for a panel date with the FDA; instead, the company will conduct more clinical trials while it waits for the Obama administration to “stabilize internal issues, resources and requirements” at the federal watchdog agency.
That forced a $2.3 billion write-down during the second quarter on impairment of goodwill, an accounting term designed to quantify a company’s perceived value in the market. The hit converted a net gain of $74 million into a $2.3 billion loss for the three-month period ended March 29.
Add that to the firm’s possible indigestion over its $580 million acquisition of Third Wave Technologies Inc. last June. Hologic won regulatory approval for a pair of human Papillomavirus tests in March, but has yet to see a significant return for its investment in Third Wave.