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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True-positive PSMA-PET with positive MRI in 74-year-old male with prostate cancer (Gleason score of 4 + 5; left anterior and posterior apex positive cores). (A) Left posterior peripheral apical to midprostate hyposignal visible on transaxial MRI. (B) No definite CT correlate evident (white arrow). (C) Focal high PSMA expression detectable in left posterior mid to base with SUVmax of 12.4 on transaxial fused delayed pelvic PET/CT (yellow arrow). (D) Focal high PSMA expression found in left midgland to base of prostate on maximum-intensity-projection image (yellow arrow).
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