The US Food and Drug Administration (FDA) has issued a final order to...
FDA reclassifies medical image analysers as class II devices
The US Food and Drug Administration (FDA) has issued a final order to reclassify select radiological medical image analysers, including computer-assisted detection (CADe) devices, from class III to class II devices.
Magnetised molecules used to monitor breast cancer
Magnetised molecules have allowed doctors to see which regions of a breast tumour are active in a carbon-13 hyperpolarised imaging scan.
FDA clears new AI system to spot stroke
The US Food and Drug Administration (FDA) has granted 501(k) clearance to radiology company Aidoc’s AI-based system for the detection of large-vessel occlusion (LVO), ischaemic strokes that result from a blockage in one of the major arteries of the brain.
Cleaning Validation for Medical Device Manufacturing
Cleaning validation or verification is a necessary regulatory compliance step in medical device manufacturing and reprocessing. Support from the cleaner manufacturer can save time and money when establishing either cleaning validation or cleaning verification.
US researchers to trial retinal scanning to diagnose Alzheimer’s
Researchers at the University of Rhode Island, Butler Hospital and BayCare Health System have collaborated to launch retinal scanning tests for early detection of Alzheimer’s disease.
PET scan allows for earlier intervention after heart attack
Research from the Society of Nuclear Medicine and Molecular Imaging indicates that a new form of positron emission tomography (PET) scanning can effectively image fibroblast activation after a heart attack.
Fujifilm reportedly planning to acquire Hitachi’s imaging business
Japanese photography and imaging company Fujifilm Holdings is reportedly planning to acquire the medical equipment business of Hitachi.
Is AI paving the way to doctorless diagnosis?
AI-driven software now regularly outperforms humans in key diagnostic tasks, raising the prospect of doctorless diagnosis in the future. So where will the rise of AI leave human diagnosticians in decades to come, and how can man and machine best collaborate with one another?
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