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3 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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NICo-Lab B.V.
Authorized purpose: Provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients using dynamic brain CT perfusion studies; medical imaging professionals use the information as additional data in the standard-of-care assessment, not as a standalone diagnostic tool.
Nico.Lab B.V.
HALO is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. Its intended use is to identify suggestive imaging patterns of a pre-specified clinical condition and to directly notify an appropriate medical specialist. HALO's indication is to facilitate the evaluation of the brain vasculature on patients suspected of stroke by processing and analyzing CT angiograms of the brain acquired in an acute setting. After completion of the data analysis, HALO sends a notification if a pattern suggestive for a suspected intracranial Large Vessel Occlusion (LVO) of the anterior circulation (ICA,MI or M2) has been identified an image. The intended users of HALO are defined as medical specialists or a team of specialists that are involved in the diagnosis and care of stroke patients at emergency departments or other department where stroke patients are administered. They include physicians such as neurologists, radiologists, and/or other emergency department physicians. HALO's output should not be used for primary diagnosis or clinical decisions; the final diagnosis is always decided upon by the medical specialist. HALO is indicated for CT scanners from GE Healthcare and Philips.
NICo-Lab B.V.
Authorized purpose: HALO analyzes contrast-enhanced brain CTA in the acute setting for suspected anterior-circulation large-vessel occlusion and provides notification support for emergency stroke specialists; the output is not a primary diagnosis.