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Machines that scan Pap slides and point the human reader to the cells most likely to be abnormal, approved in the United States from 1995 onwards.
Three automated readers hold FDA approvals under the product code for automated cervical cytology slide readers. The AutoPap 300 QC system (PMA P950009, 29 September 1995) was renamed the FocalPoint System in 2001 (applicant BD Diagnostics, of Becton, Dickinson and Company), and the BD FocalPoint GS Imaging System, approved on 3 December 2008, assists cervical screening of SurePath slides and ranks them by the likelihood of abnormality. The ThinPrep Imaging System (Hologic, PMA P020002, 6 June 2003) is indicated for assisting in primary cervical cancer screening of ThinPrep Pap slides for atypical cells, cervical neoplasia and its precursor lesions. The first, the Papnet Testing System (PMA P940029, approved 8 November 1995), is recorded by the FDA as withdrawn. The digital successor with an artificial intelligence algorithm is a separate record.
An imaging system scans Pap slides and ranks them, or directs the cytologist to the fields most likely to hold abnormal cells.
| Region | Year | Indication |
|---|---|---|
| US | 1995 | AutoPap 300 QC, later FocalPoint (PMA P950009) |
| US | 2003 | ThinPrep Imaging System, assisting in primary cervical cancer screening of ThinPrep Pap slides (PMA P020002) |
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Query for this drug: (TITLE:"Automated Pap slide readers: BD FocalPoint and the ThinPrep Imaging System" OR ABSTRACT:"Automated Pap slide readers: BD FocalPoint and the ThinPrep Imaging System" OR TITLE:"BD FocalPoint" OR ABSTRACT:"BD FocalPoint" OR TITLE:"FocalPoint GS Imaging System" OR ABSTRACT:"FocalPoint GS Imaging System" OR TITLE:"ThinPrep Imaging System" OR ABSTRACT:"ThinPrep Imaging System" OR TITLE:"Papnet" OR ABSTRACT:"Papnet") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Automated Pap slide readers: BD FocalPoint and the ThinPrep Imaging System, not a curated reading list.
Shares BD SurePath liquid-based Pap test and PrepStain slide processor, BD (Becton, Dickinson and Company), FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL) and the tags test, screening-test.
Shares ThinPrep Pap Test and ThinPrep processors (Hologic), FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling and the tags test, screening-test.
Shares ThinPrep Pap Test and ThinPrep processors (Hologic), FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling, Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling, Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling, Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), HPV DNA testing and self-sampling, Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
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