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BioWorld - Thursday, December 18, 2025
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Home » FDA, MDIC keen on ramping up early feasibility studies for neurological devices
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FDA, MDIC keen on ramping up early feasibility studies for neurological devices

June 3, 2021
By Mark McCarty
Early feasibility studies for cardiology devices were a massive problem for the FDA and industry in times gone by, a problem that was believed to drive device flight from the U.S. That problem has been largely solved, according to the FDA’s Andrew Farb, but Farb noted that neurological devices are the next target for improved early feasibility study (EFS) development in the U.S., which suggests that the path to pivotal studies for devices in this space will soon be much less cumbersome.
BioWorld MedTech Regulatory Neurology/psychiatric U.S. CMS FDA

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