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

First GammaTile Therapy Case Completed in Arizona
News | Radiation Therapy | August 19, 2019
HonorHealth Scottsdale Osborn Medical Center is the first hospital in Arizona to begin offering GammaTile Therapy, a...
Lunit Receives Korea MFDS Approval for Lunit Insight MMG
News | Artificial Intelligence | August 19, 2019
Lunit has announced Korea Ministry of Food and Drug Safety (MFDS) approval of its artificial intelligence (AI) solution...
Drug Accelerates Blood System's Recovery After Radiation, Chemotherapy

Following radiation, the bone marrow shows nearly complete loss of blood cells in mice (left). Mice treated with the PTP-sigma inhibitor displayed rapid recovery of blood cells (purple, right). Credit: UCLA Broad Stem Cell Research Center/Nature Communications

News | Radiation Therapy | August 16, 2019
A drug developed by UCLA physician-scientists and chemists speeds up the regeneration of mouse and human blood stem...
Mevion and C-RAD Release Integration for Improved Proton Therapy Treatment Quality

Catalyst PT image courtesy of C-RAD

News | Patient Positioning Radiation Therapy | August 15, 2019
Mevion Medical Systems and C-RAD announced the integration between the C-RAD Catalyst PT and the Mevion S250i proton...
First Patient Enrolled in World's Largest Brain Cancer Clinical Trial
News | Radiation Therapy | August 15, 2019
Henry Ford Cancer Institute is first-in-the-world to enroll a glioblastoma patient in the GBM AGILE Trial (Adaptive...
Efficacy of Isoray's Cesium Blu Showcased in Recent Studies
News | Brachytherapy Systems | August 14, 2019
August 14, 2019 — Isoray announced a trio of studies recently reported at scientific meetings and published in medica
Imago Systems Announces Collaboration With Mayo Clinic for Breast Imaging

Image courtesy of Imago Systems

News | Mammography | August 14, 2019
Image visualization company Imago Systems announced it has signed a know-how license with Mayo Clinic. The multi-year...
Artificial Intelligence Could Yield More Accurate Breast Cancer Diagnoses
News | Artificial Intelligence | August 13, 2019
University of California Los Angeles (UCLA) researchers have developed an artificial intelligence (AI) system that...
Lake Medical Imaging Selects Infinitt for Multi-site RIS/PACS
News | PACS | August 09, 2019
Infinitt North America will be implementing Infinitt RIS (radiology information system)/PACS (picture archiving and...