Hologic wins FDA approval for pap test imaging device
Photo | Google
Hologic's Marlborough location
Marlborough women’s health device manufacturer Hologic has won a federal approval for a device the company says can analyze pap tests in 90 seconds.
The company announced last week its premarket approval from the U.S. Food and Drug Administration for its ThinPrep Integrated Imager.
Now, the company’s automated imaging of pap tests will be more broadly available in laboratories of all sizes, Hologic said in a press release. A pap tests checks a woman's cervix for abnormalities to detect issues like cervical cancer.
"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," said Tom West, president of the diagnostic solutions division at Hologic.
Most of the company’s Pap tests are run in high-volume reference laboratories. The new device, combined with Hologic’s ThinPrep Pap tests, will become more available in smaller labs.
According to Hologic, the device guides technicians to areas showing potential abnormal cells and images slides in about 90 seconds and combines an imaging station and review scope into a single desktop system.
The device can also be used as a conventional microscope, Hologic said.
WBJ Web Partners
Most Recent
Most Recent
0 Comments