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Elon Musk's Neuralink gets FDA breakthrough device tag for 'Blindsight' implant

Economic Times

Economic Times · 11m ago

Elon Musk's Neuralink gets FDA breakthrough device tag for 'Blindsight' implant

Neuralink, Elon Musk's brain-chip startup, has received FDA's breakthrough device designation for its experimental implant designed to restore vision. The device, called Blindsight, aims to enable sight for individuals who have lost both eyes and their optic nerve. Neuralink's brain chip interface, implanted within the skull, could potentially help disabled patients move, communicate, and see again. The company is also testing an implant to assist paralyzed patients in using digital devices through thoughts alone. Neuralink successfully implanted the device in a second patient earlier this year.

Related News

Elon Musk’s Neuralink to implant Blindsight prosthesis in a human by 2025 end

Economic Times

Economic Times · 5m ago

Elon Musk’s Neuralink to implant Blindsight prosthesis in a human by 2025 end

Elon Musk's Neuralink aims to implant its Blindsight visual prosthesis in a human by 2025's end, potentially restoring sight to the completely blind. Initially offering low-resolution vision, Blindsight aspires to eventually surpass normal human sight levels. Neuralink, founded in 2016, focuses on creating a brain interface to restore autonomy in individuals with medical challenges. The FDA granted Blindsight breakthrough status in 2022, and Neuralink has already conducted implant trials with human participants.

Exclusive: US lawmaker seeks answers on FDA inspection of Musk's Neuralink

Reuters · 1y ago

Exclusive: US lawmaker seeks answers on FDA inspection of Musk's Neuralink

A U.S. lawmaker, Representative Earl Blumenauer, has questioned the Food and Drug Administration (FDA) regarding its decision to allow Elon Musk's Neuralink to test its brain implant device in humans without conducting an inspection. Last June, FDA inspectors found issues with record keeping and quality controls for animal experiments at Neuralink. Blumenauer expressed concerns about alleged animal testing violations and requested an explanation from the FDA. Neuralink has not responded to these inquiries. Other brain implant companies, such as Synchron and Blackrock Neurotech, have also conducted human testing with their devices.

‘Most enduring gift to humankind’: Anand Mahindra excited about Elon Musk-owned Neuralink’s ‘Blindsight’ device | Mint

Livemint

Livemint · 11m ago

‘Most enduring gift to humankind’: Anand Mahindra excited about Elon Musk-owned Neuralink’s ‘Blindsight’ device | Mint

Chairperson of Mahindra and Mahindra, Anand Mahindra, praised Elon Musk's latest neurotechnology innovation. Sharing Musk's post about Neuralink's Blindsight device, Mahindra stated that if the device lives up to expectations, it could be Musk's most enduring gift to humankind. Musk's post detailed the capabilities of the Blindsight device, which aims to restore vision to those with blindness. The device has received a "Breakthrough Device" designation from the FDA, allowing for expedited development and review processes. While the initial visual output may be low-resolution, future iterations could potentially surpass natural human vision.

US lawmaker seeks answers on FDA inspection of Musk's Neuralink

Economic Times

Economic Times · 1y ago

US lawmaker seeks answers on FDA inspection of Musk's Neuralink

Democratic U.S. Representative Earl Blumenauer has raised concerns about the Food and Drug Administration's (FDA) decision to allow Elon Musk's Neuralink to test its brain implant device in humans without prior inspection. The FDA had found issues with record keeping and quality controls for animal experiments conducted by Neuralink. Blumenauer highlighted reports of animal testing violations, rushed schedules, and concerns over data quality. He called on the FDA to justify its decision and address the alleged lapses. The FDA stated that it would respond directly to Blumenauer and that inspections are routinely conducted after approval for human trials. Neuralink has not yet responded to the issue.

US FDA cited animal lab at Musk's Neuralink for 'objectionable conditions'

Economic Times

Economic Times · 8m ago

US FDA cited animal lab at Musk's Neuralink for 'objectionable conditions'

The Food and Drug Administration (FDA) has cited Elon Musk's Neuralink for objectionable conditions and practices in its animal testing laboratory. This comes after FDA inspectors identified the issues in June 2023. While the FDA stated that the concerns did not undermine the safety of Neuralink's brain implant device, it urged the company to take voluntary remediation measures to address the problems. Neuralink has previously faced internal staff complaints about rushing experiments, causing suffering and deaths of animals. The company aims to assist individuals with paralysis and other disorders using brain-chip technology.

Neuralink gets FDA nod for second patient, as first describes his journey

Livemint

Livemint · 1y ago

Neuralink gets FDA nod for second patient, as first describes his journey

Elon Musk's Neuralink has received approval from the U.S. FDA to implant its brain chip in a second person after addressing issues that arose in the first test participant. The proposed fixes involve embedding the device's ultrathin wires deeper into the brain. The first participant, Noland Arbaugh, experienced significant improvements in controlling a computer cursor with his thoughts initially, but after a month, most of the implanted wires had come loose. Arbaugh expressed disappointment but is hopeful for future improvements after Neuralink made software changes and found ways to stabilize the remaining wires. The company plans to implant 10 more people this year.

The FDA reportedly identified quality-control issues at a Neuralink animal lab shortly after Elon Musk said the startup was cleared to start human tests

Business Insider

Business Insider · 1y ago

The FDA reportedly identified quality-control issues at a Neuralink animal lab shortly after Elon Musk said the startup was cleared to start human tests

The US Food and Drug Administration (FDA) has reportedly found issues with record-keeping and quality controls for animal experiments at Elon Musk's Neuralink facility in California. The issues, identified between June 12 and 22, 2023, were not deemed significant enough for regulatory action by the FDA. Neuralink, which aims to implant brain chips to enable human-computer interaction, had announced FDA approval for human trials in May 2023. The company's Texas site did not have the same problems. This is not the first time Musk's ventures have faced regulatory scrutiny, with previous reports of mistreatment of animals and workplace safety concerns.

Elon Musk's Neuralink to launch feasibility trial with brain implant, robotic arm

Economic Times

Economic Times · 9m ago

Elon Musk's Neuralink to launch feasibility trial with brain implant, robotic arm

Elon Musk's Neuralink has been granted approval to conduct a feasibility study using its brain implant and a robotic arm. The study aims to assess the safety and effectiveness of the wireless brain-computer interface in quadriplegic patients, enabling them to control external devices with their thoughts. Participants will be enrolled from Neuralink's ongoing PRIME trial. The U.S. FDA and Neuralink have yet to provide additional information. This comes after Neuralink received approval to conduct a trial of its device in Canada, where neurosurgeons will recruit six paralyzed patients. The device has shown promising results in the two American patients who have already been implanted with it.

Neuralink video shows patient using brain implant to play chess on laptop

The Verge

The Verge · 1y ago

Neuralink video shows patient using brain implant to play chess on laptop

Elon Musk's company Neuralink has released a video showing a paralyzed patient controlling a mouse cursor and playing chess using the brain implant technology. The patient, Noland Arbaugh, described the experience as using the Force from Star Wars. In addition to playing chess, Arbaugh was also able to play the video game Civilization VI for eight hours straight using the implant. Neuralink received permission from the FDA to conduct in-human clinical trials last year, and this video marks the first time a human using the implant has been shown. Critics have raised concerns about transparency and the ethical treatment of animals in Neuralink's trials.

Neuralink to implant second brain chip next week, says Elon Musk

Livemint

Livemint · 1y ago

Neuralink to implant second brain chip next week, says Elon Musk

Elon Musk's brain-computer startup, Neuralink, plans to implant its device into a second human patient within a week. The first patient, Noland Arbaugh, received the brain chip implant after a paralyzing accident in 2016. Neuralink executives have stated that the implant has become stable and they hope to have high single-digit implantations by the end of the year. The long-term goal of Neuralink is to establish a closer connection between human intelligence and digital intelligence, ultimately mitigating AI risks. The brain implant allows paralyzed patients to use digital devices through brain signals, enabling actions like moving a cursor on a screen.

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