Drug/Device and Device/Drug Combinations in the EU and USA

Sep 30th, 2015Oct 1st, 2015
London, H9
GB
http://www.management-forum.co.uk/medical-devices/events/drugdevice-devicedrug-combinations-in-the-eu-and-usa/
Phone:+44 (0) 1473 730071
Practical guidance on borderline issues and combination products.
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Cropped secondary capture examples. These are illustrative and not intended to imply superiority or inferiority of any device. (A) Posteroanterior radiograph in a 46-year-old female patient. The device correctly identified a right lower lobe nodule projected below the right hemidiaphragm and hilar lymphadenopathy. (B) Posteroanterior radiograph in an 86-year-old female patient with a classic Golden S sign highly suggestive of cancer. Three devices did not identify any findings. (C) The output from one device for the same radiograph as in B. The device placed a contour around the area of abnormality but mislabeled it as segmental collapse, and there are no other elements in the output to raise suspicion of cancer. (D) Posteroanterior radiograph in a 60-year-old male patient -- a case of confirmed lung cancer that was not deemed visible in retrospect. The device identified multiple false-positive abnormalities. (E) Posteroanterior radiograph in a 77-year-old female patient with two right lower lobe nodules. The device mislabeled the abnormality as infection -- a diagnostic term that could incorrectly influence clinical management. (F) Posteroanterior radiograph in a 77-year-old female patient with a right hilar tumor. Most of the lungs have been labeled by the device, with excessive overlap of the abnormality that pragmatically represents an incorrect result. All annotations shown were produced by the devices. LL = lung lesion, LO = lung opacity, PO = pleural other, TBC = tuberculosis.
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