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Nov 19, 2018
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Most FDA-cleared AI medical devices not tested on patient outcomes
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(A) Ga-68 NK224 PET/CT maximum intensity projection image (left), axial PET/CT images (center), and axial CT images (right) in a 43-year-old female participant with lung adenocarcinoma show lesions in the right cerebellum (blue arrow), right frontal lobe (red arrow), and sternum (green arrow) with low, intermediate, and high tracer uptake, respectively. Photomicrographs (scale bar, 100 μm) with hematoxylin-eosin (H&E) staining (center bottom) and programmed death ligand 1 (PD-L1) immunohistochemical (IHC) staining (right bottom) show high PD-L1 expression in the sternal lesion (tumor proportion score ≥ 50%).
New immuno-PET tracer shows promise in lung cancer
August 18, 2026
Artificial intelligence (AI) assistance facilitates correct fracture identification in cases initially missed by human readers. A representative case is shown using anteroposterior radiographs in a 29-year-old male patient with wrist trauma (suspected nondisplaced transverse scaphoid fracture). The reader’s initial unaided assessment (top) resulted in a missed fracture, whereas with AI assistance (bottom), the fracture was correctly identified. The green box represents the fracture location as predicted by the AI tool, the blue box represents the reference standard annotation, and the red dots represent individual reader annotations.
AI fracture detection device validated across three European hospitals
August 18, 2026
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Most FDA-cleared AI medical devices not tested on patient outcomes
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(A) Ga-68 NK224 PET/CT maximum intensity projection image (left), axial PET/CT images (center), and axial CT images (right) in a 43-year-old female participant with lung adenocarcinoma show lesions in the right cerebellum (blue arrow), right frontal lobe (red arrow), and sternum (green arrow) with low, intermediate, and high tracer uptake, respectively. Photomicrographs (scale bar, 100 μm) with hematoxylin-eosin (H&E) staining (center bottom) and programmed death ligand 1 (PD-L1) immunohistochemical (IHC) staining (right bottom) show high PD-L1 expression in the sternal lesion (tumor proportion score ≥ 50%).
AI fracture detection device validated across three European hospitals
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Artificial intelligence (AI) assistance facilitates correct fracture identification in cases initially missed by human readers. A representative case is shown using anteroposterior radiographs in a 29-year-old male patient with wrist trauma (suspected nondisplaced transverse scaphoid fracture). The reader’s initial unaided assessment (top) resulted in a missed fracture, whereas with AI assistance (bottom), the fracture was correctly identified. The green box represents the fracture location as predicted by the AI tool, the blue box represents the reference standard annotation, and the red dots represent individual reader annotations.
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