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Neuralink says the FDA designated its Blindsight implant as a 'breakthrough device'
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Neuralink says the FDA designated its Blindsight implant as a 'breakthrough device'
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Yesterday, 08:47
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| [M] Reviewer  Join Date: May 2010 Location: Romania
Posts: 152,436
 |  Neuralink says the FDA designated its Blindsight implant as a 'breakthrough device' Manufacturers who apply to the FDA's voluntary breakthrough devices program and receive the designation from the agency are granted "an opportunity to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase.” The FDA also prioritizes breakthrough devices for review. Ultimately, a breakthrough device designation can accelerate development of a technology. Last year, the FDA gave the designation to 145 medical devices. https://www.engadget.com/science/neu...6.html?src=rss |
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