The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...

FDA issues warning to Hologic, citing manufacturing and safety violations for BioZorb devices. Patient safety risks and reporting failures highlighted ...

Enough evidence for jury to consider failure to warn claim Case is one of nearly two dozen Hologic faces over BioZorb Hologic Inc. can’t shake a woman’s suit alleging the medical device manufacturer ...

Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.

Hologic Inc. has received a warning letter from the Food and Drug Administration regarding its BioZorb product line, even though the company recalled the devices last year.

Shares of Hologic HOLX recorded a new 52-week low of $69.46 during Monday’s trading before finishing slightly higher at $70.29. Yesterday, the stock ended at $70.20, marking the lowest close in recent ...

Rishell accused the company of negligently designing, manufacturing and marketing the BioZorb device. The device is used to assist in radiation treatment of breast cancer by identifying breast ...

The Food and Drug Administration on Monday released much-anticipated testing recommendations for pulse oximeters. The draft guidance follows years of discussion about concerns that the devices can be ...