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Neuralink says the FDA designated its Blindsight implant as a 'breakthrough device'

<p><a data-i13n="cpos:1;pos:1" href="https://www.engadget.com/tag/neuralink/">Neuralink[/url] says the Food and Drug Administration has <a data-i13n="cpos:2;pos:1" href="https://www.reuters.com/business/healthcare-pharmaceuticals/musks-neuralink-receives-fdas-breakthrough-device-tag-brain-implant-2024-09-17/">designated[/url] its experimental Blindsight implant as a "breakthrough device." The company is developing the technology in an attempt to restore blind people's sight.</p>
<p>Manufacturers who apply to the FDA's voluntary <a data-i13n="cpos:3;pos:1" href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program">breakthrough devices program[/url] 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.</p>
<span id="end-legacy-contents"></span><p>Blindsight is separate from Telepathy, its implant that enables patients with spinal cord injuries to <a data-i13n="cpos:4;pos:1" href="https://www.engadget.com/heres-a-video-of-the-first-human-neuralink-patient-controlling-a-computer-with-his-thoughts-235659486.html">control computers[/url] using their thoughts, allowing them to play video games and design 3D objects. Neuralink owner and founder Elon Musk <a data-i13n="cpos:5;pos:1" href="https://www.engadget.com/neuralink-successfully-implants-its-chip-into-a-second-patients-brain-123013864.html">said in August[/url] that the company had implanted the chip into a second human patient</p>
<p>Musk <a data-i13n="cpos:6;pos:1" href="https://x.com/elonmusk/status/1770817187285995939">claimed back in March[/url] that Blindsight "is already working in monkeys. Resolution will be low at first, like early Nintendo graphics, but ultimately may exceed normal human vision." (Federal investigators have <a data-i13n="cpos:7;pos:1" href="https://www.engadget.com/neuralink-federal-investigation-animal-testing-071953787.html">reportedly looked into Neuralink's animal testing practices[/url] but Musk said in March that "no monkey has died or been seriously injured by a Neuralink device.")</p>
<div id="1e315c72c5114f3e9a9edb7577d6eba8"><blockquote class="twitter-tweet"><p lang="en" dir="ltr">The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see.

Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.

To set expectations correctly, the vision… https://t.co/MYLHNcPrw6 (https://t.co/MYLHNcPrw6) pic.twitter.com/RAenDpd3fx (https://t.co/RAenDpd3fx)</p>— Elon Musk (@elonmusk) September 17, 2024 (https://twitter.com/elonmusk/status/1836120537883644049?ref_src=twsrc%5Etfw)
 

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<p>Blindsight "will enable even those who have lost both eyes and their optic nerve to see," <a data-i13n="cpos:8;pos:1" href="https://x.com/elonmusk/status/1836120537883644049">Musk said[/url] following the FDA's designation. "Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time." He added that while the resolution of Blindsight is low to begin with, "eventually it has the potential [to] be better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths."</p>
<p>Those are lofty claims and Neuralink is some way off from being able to fully restore sight to someone who has lost it, if it’s ever actually able to do that. It's not the first company or research team to work on <a data-i13n="cpos:9;pos:1" href="https://www.engadget.com/2013-02-15-fda-clears-argus-ii-bionic-eye-for-sale-in-the-us-video.html">vision-restoring implants[/url] either. Meanwhile, as <a data-i13n="elm:context_link;elmt:doNotAffiliate;cpos:10;pos:1" class="no-affiliate-link" href="https://techcrunch.com/2024/09/17/neuralinks-breakthrough-device-clearance-from-fda-does-not-mean-they-have-cured-blindness/" data-original-link="https://techcrunch.com/2024/09/17/neuralinks-breakthrough-device-clearance-from-fda-does-not-mean-they-have-cured-blindness/">TechCrunch[/url] points out, it's unlikely that Blindsight or similar tech can help people who have been blind since birth, given that such people have not "developed the biological capacity for seeing through their eyes."</p>This article originally appeared on Engadget at https://www.engadget.com/science/neuralink-says-the-fda-designated-its-blindsight-implant-as-a-breakthrough-device-182343456.html?src=rss

Source: Neuralink says the FDA designated its Blindsight implant as a 'breakthrough device' (https://www.engadget.com/science/neuralink-says-the-fda-designated-its-blindsight-implant-as-a-breakthrough-device-182343456.html?src=rss)