Hologic wins FDA PMA for ThinPrep automated Pap test imager

Hologic (NSDQ:HOLX) said today it won FDA premarket approval for its ThinPrep integrated imager designed for the automated imaging of Pap tests.

The Marlborough, Mass.-based company’s ThinPrep imager is designed to aid cytology technicians in identifying abnormal cells, and combines an imaging station and review scope into a single unit. The system takes approximately 90 seconds to analyze samples, the company said.

“Approval of the ThinPrep Integrated Imager brings the benefits of ThinPrep automated Pap imaging to small- and mid-sized laboratories in the United States, and of course to their patients. Development of this newest ThinPrep product confirms Hologic’s commitment to women’s health and specifically to robust and accessible screening strategies for cervical cancer,” Hologic diagnostic solutions prez Tom West said in a prepared statement.

Hologic said that, in conjunction with the clearance, it is launching its Compass Stainer in the US. The system is an automated stainer designed for both routine and special staining protocols, the company said.

Earlier this month, Hologic released results from a study comparing its NovaSure endometrial ablation system to Minerva Surgical‘s endometrial ablation device, touting a higher one-year rate of amenorrhea and higher quality of life for women treated with the NovaSure, despite experiencing a higher rate of perioperative adverse events.

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