NEW YORK (360Dx) – Hologic announced today that the US Food and Drug Administration has granted premarket approval for its ThinPrep Integrated Imager, which the firm said will allow automated imaging tests to become more widely available to laboratories and cytologists in the US.
The ThinPrep system integrates computer-assisted imaging and dual slide review into a single, automated microscope that will potentially increase sensitivity for cervical disease detection.
Hologic's pap imaging device indicates areas of potential abnormal cells that indicate pre-cancerous and cancerous process in the cervix. It is able to image slides in about 90 seconds.
Tom West, president of the diagnostic solutions division at Hologic, said in a statement that the FDA approval will bring the benefits of ThinPrep automated pap imaging to small and mid-sized laboratories in the US and their patients.
In addition to the ThinPrep system, Hologic is also launching the Compass Stainer in the US, which is a smaller footprint automated stainer that performs both routine and special staining products.