Marlborough-based medical device manufacturer Hologic has been issued a warning letter from the U.S. Food and Drug Administration concerning its BioZorb Marker, a device originally recalled in March.

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX), a global leader in women's health, will launch the NovaSure® V5 global endometrial ablation (GEA) device at the American Association ...

On Friday, the FDA warned against using Hologic Inc.’s (NASDAQ:HOLX) BioZorb Marker products and urged healthcare facilities to return all unused lots. This follows Hologic’s voluntary recall of the ...

Wrapping up Q3 earnings, we look at the numbers and key takeaways for the medical devices & supplies - imaging, diagnostics ...

ARLINGTON, Va.--(BUSINESS WIRE)--The National Evaluation System for health Technology (NEST), an initiative of the Medical Device Innovation Consortium (MDIC), is pleased to welcome Hologic, a leading ...

The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland (Reuters) - The U.S. health regulator on Tuesday warned patients and healthcare providers about the ...

HOLX nears its 52-week high on diagnostics growth and AI adoption, while tariffs and challenges in China continue to pose risks.

Marlborough, Mass.-based Hologic closed a $160 million purchase of Louisville, Colo.-based devicemaker Bolder Surgical, according to a Nov. 30 news release. The acquisition adds laparoscopic vessel ...

A new study has demonstrated the safety and clinical effectiveness of a device Hologic is developing to aid with breast surgery. The study published in the Annals of Surgical Oncology, which Hologic ...

The Food and Drug Administration issued a warning letter to Hologic Inc. (NASDAQ:HOLX), citing violations in the manufacturing and reporting processes for its BioZorb product line. The letter, ...

A new private-label deal will see Hologic Inc. distributing a soft tissue biopsy instrument manufactured by Angiotech Pharmaceuticals Inc. Angiotech Pharmaceuticals Inc. (NSDQ:ANPI) inked a three-year ...

Over the last 20 years, the NovaSure system has built a trusted legacy in GEA. The NovaSure device first received FDA approval in 2001, and by 2018 the NovaSure procedure had been used to treat over 3 ...