Hologic gets FDA clearance for women's bacterial diagnostic
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Hologic's Marlborough headquarters
Marlborough medical device firm Hologic has won regulatory approval to diagnose infections the company says impact an estimated 21 million women a year.
U.S. Food and Drug Administration approval for the product Aptima, which Hologic announced Wednesday, clears the way for a new diagnosis for vaginitis, which is often caused by a bacteria or an infection.
Hologic did not say when the new products could begin use on patients.
The Aptima BV and CV/TV products will provide an accurate and objective diagnosis method for something today is often self-diagnosed and self-treated or mistaken for a yeast infection, Hologic said. Vaginitis is one of the most common reasons women visit a healthcare provider, the company said, and an early diagnosis can improve treatment from an initial medical visit.
CORRECTION: A previous version of this story incorrectly said Aptima is a vaginitis treatment. It is a diagnostic.
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