In-vitro Diagnostics Directive

May 18th, 2011
London, --
GB
https://www.management-forum.co.uk/medical/eventid/1580
Clarify the requirements applicable for IVDs, understand the future changes to the Directive and the implications for the industry, and gain knowledge on supplier control and validation.
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A graphical abstract of the study.
FDG-PET/CT predicts outcomes in patients with HCC
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Multimodal brain health composites outperform standard AD biomarkers
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FDG-PET/CT predicts outcomes in patients with HCC
By Will Morton
Elevated FDG uptake was consistently associated with poorer overall survival.
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A graphical abstract of the study.
Multimodal brain health composites outperform standard AD biomarkers
By Kate Madden Yee
"Reproducible, multimodal composites can capture distinct yet complementary dimensions of brain health," researchers noted.
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Brain Abstract
CEM shows strong performance in diagnosing DCIS
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CEM showed higher sensitivity than low-energy imaging in diagnosing DCIS by pathological nuclear grading.
May 22, 2026
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Katja Pinker, MD, PhD, discusses the current state of breast MRI and her time at ISMRM 2026.
May 22, 2026
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Radiomics model grades hand osteoarthritis on x-rays
By Will Morton
Hand osteoarthritis affects approximately 8% of men and 16% of women over the age of 50.
May 21, 2026
Overlap between manual (radiologist) and semiautomatic (algorithm) segmentations of hand joints on a standard posteroanterior radiograph. Orange overlay indicates manual radiologist segmentations, blue overlay shows algorithm segmentations, and green overlay indicates consistent regions between both methods.
Despite pediatric ED imaging capability, race and insurance gaps remain
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More work is needed to ensure pediatric imaging in the ED addresses both quality and equity of care, according to investigators.
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MRI-specific AI algorithm reads cardiac scans with up to 99% accuracy
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The algorithm beat existing general-purpose AI models by up to 35%, researchers reported.
May 21, 2026
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Are RFPs still needed for buying a PACS? Michael J. Cannavo, aka the PACSMan, tackles this question in episode 2 of The PACSMan Pontificates podcast series.
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TAE reduces pain in patients with chronic wrist pain
By Will Morton
The finding suggests that the emerging interventional radiology procedure could be a new option for patients who have exhausted conservative management.
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A 44-year-old woman with TFCC injury treated by transcatheter arterial embolization (TAE). a) Right brachial arteriography via common femoral artery access with a 5-Fr catheter demonstrates hyperstaining on the ulnar side of the wrist joint (white circle). b) An ulnar artery branch is superselected with a 1.9-Fr microcatheter, showing hypervascular staining corresponding to the pain site (white arrow). c) Delayed-phase angiography reveals early venous drainage (white arrow) adjacent to the hyperstaining, a finding often observed in TAE and considered an additional marker for embolization. d) Final angiography after injection of 0.5 mL quick-soluble gelatin sponge particles (QS-GSPs) demonstrates resolution of the hyperstaining (white circle). The VAS pain score improved from 7 at baseline to 1 at six months.
Human-AI collaboration beats AI alone for identifying PE
By Kate Madden Yee
Study findings highlight the continued central role of radiologists for this indication.
May 20, 2026
Case example of a false-negative AI result. An 85-year-old female presented to the emergency department with dyspnea. Axial 0.625-mm from CT pulmonary angiography examination with contrast (CTPA) images demonstrate a thin, linear right-sided filling defect extending from the right interlobar pulmonary artery (A and B, red arrows) into the right middle lobar artery (B, yellow arrow), consistent with acute pulmonary embolism (PE). The finding was described in the radiology report; however, the AI result was negative for PE. Adjudication was consistent with acute PE.
AI model predicts 10-year breast cancer risk
By Amerigo Allegretto
A mammography-based AI model showed strong performance in predicting 10-year breast cancer risk over clinical and other AI models.
May 20, 2026
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AI devices vary widely in lung cancer detection
By Will Morton
Three devices helped detect more cancerous tumors, whereas the other four devices helped detect fewer tumors.
May 19, 2026
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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