Stroke is due to a large vessel occlusion in the brain. Stroke impacts over 600, 000 per year and is the leading disease for long-term morbidity in adults in the United States. Currently only 10% of adults who quality for intervention currently receive treatment. A computer-aided decision support tool has been proposed as a tool to accelerate patient care from the time of diagnosis to thrombolytic treatment.
In mid-February, the FDA approved the Viz. AI, a deep learning, decision support, computer software to alert physicians for possible large-vessel occlusion stroke in patients. The software would analyze the CT Head immediately and send a text message directly to the interventionists for review of the case.
Per FDA, "The Viz.AI computer application was reviewed through the De Novo review pathway, a regulatory pathway for some new types of medical devices that are low to moderate risk and have no legally marketed predicate device to base a determination of substantial equivalence. This action also creates a new regulatory classification, which means that subsequent computer-aided triage software devices with the same medical imaging intended use may go through the FDA’s premarket notification (510 (k)) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device".
-This is incredible! This means time to treatment will be reduced and better care for patients; this could also mean more patients can get treatment
-Typically, radiologists interpret these studies and alert the neurologists; but the software bypasses the current process altogether.
-The approval sets the stage and process for how other decision support software can get FDA approval without requiring expensive randomized control studies, which is a huge win for the developers, engineers, entrepreneurs and ultimately patients.