Why is the Neurolumen Device FDA cleared not aproved?
Neurolumen is FDA cleared, meaning it incorporates the same or closely related technology, that has been previously approved by the FDA. The FDA determined it was substantially equivalent to predicate devices. This determination is made by the FDA after a product is submitted. The FDA decides if the product does contain technology that is enough like the previously approved devices that it will pose similar risks to the public. If the FDA make this determination the product then becomes cleared by FDA to market to the citizens of the United States.
FDA approval is used when there is not a predicate device to compare the new or repurposed device. The submitting company will have to file their pre-market approval application with all of the study data and then the FDA will have to determine if that is enough data to prove that the benefits outweigh the risk to the consumer. It will then either ask for more studies to be or it will approve the device to be marketed.