News | September 29, 2009

Hologic Gets CE Mark for Cervical Cancer Screening Imager Device

September 29, 2009 - Hologic Inc. has received CE marking approval for its ThinPrep integrated imager, a cervical cancer screening device that was introduced and on display at the 35th European Congress of Cytology this week in Lisbon, Portugal.

The integrated imager combines ThinPrep imaging technology and slide review into a single, convenient stand-alone device. This new product offering allows laboratories of all sizes to benefit from clinical advantages of ThinPrep imaging for cervical screening.

"This represents a tremendous opportunity for Hologic and our current and future laboratory partners throughout Europe," said Howard Doran, senior vice president, diagnostics products for Hologic. "The ThinPrep integrated imager is designed to provide the small and medium volume laboratory access to the most effective and efficient cytology screening technology available, while allowing them the flexibility to address their specific productivity and throughput needs." The majority of laboratories in Europe would fall into the small or medium category.

The integrated imager analyzes a ThinPrep Pap test slide in approximately 90 seconds, during which time each cell and cell cluster is scanned. Using optical density analysis, the integrated imager identifies diagnostically-relevant cells or cell groups and then stores coordinates of the 22 fields of interest. These 22 fields of interest are presented to the cytotechnologist for interpretation. If no abnormalities are identified by the cytotechnologist, the slide can be signed out as negative or proceed through the laboratory quality control system. A complete slide review is required if the user detects any suspicious cells within the 22 fields of view. This dual review process combines human interpretative expertise with the power of computer imaging. The integrated imager can also be used as a conventional microscope saving valuable lab space.

CE marking approval allows Hologic to market the ThinPrep integrated imager in the 27 countries of the European Union (EU) and three of the four member states of the European Free Trade Association (EFTA). CE marking is recognized in many countries outside the European Economic Area giving Hologic the ability to supply systems to a number of markets internationally. The ThinPrep integrated imager is currently not approved by the U.S. Food and Drug Administration.

For more information: www.hologic.com

Related Content

PET Scans Show Biomarkers Could Spare Some Breast Cancer Patients from Chemotherapy
News | PET Imaging | March 18, 2019
A new study positron emission tomography (PET) scans has identified a biomarker that may accurately predict which...
Fujifilm Launches Three New Software Tools for Aspire Cristalle Digital Mammography System
Technology | Mammography | March 15, 2019
Fujifilm Medical Systems USA announced it has fulfilled all U.S. Food and Drug Administration (FDA) regulatory...
Hologic Receives CE Mark for Three-in-One Omni Hysteroscope
News | Endoscopes | March 14, 2019
Hologic Inc. announced it has received a CE mark in Europe for its Omni hysteroscope, a three-in-one modular scope with...
CT, Mammograms Offer Clues to Preventing Heart Problems After Cancer Treatment
News | Cardio-oncology | March 13, 2019
An imaging procedure commonly performed before starting cancer treatment can provide valuable clues about a patient's...
Sponsored Content | Videos | Artificial Intelligence | March 13, 2019
At RSNA 2018, iCad showed how its...
Mississippi Cancer Center Combines RayStation and TomoTherapy for Prostate Cancer Case
News | Treatment Planning | March 08, 2019
Anderson Regional Cancer Center in Meridian, Miss., has treated its first patient using the combination of RaySearch's...
Hologic Earns CE Mark for LOCalizer Wireless Breast Lesion Localization System
News | Breast Imaging | March 07, 2019
Hologic Inc. announced the granting of a CE Mark to the LOCalizer wireless radio frequency identification (RFID) breast...
South Dakota's Density Inform Bill Signed Into Law
News | Breast Density | March 06, 2019
With the passage of HB1124, South Dakota becomes the 37th state with breast density inform legislation. The law, which...
iCAD Partnering With Karolinska Instituet Researchers on AI-based Breast Cancer Risk Prediction
News | Oncology Diagnostics | March 04, 2019
iCAD announced their intent to enter an exclusive relationship with two leading researchers at The Karolinska...
Videos | Proton Therapy | February 28, 2019
ITN Associate Editor Jeff Zagoudis speaks with ...