Elon Musk's brain-implant company Neuralink on Thursday said it had received the US Food and Drug Administration's approval to launch its first in-human clinical study.
At least four times since 2019, Mr Musk has predicted that his medical device company would soon start human trials of a brain implant to treat intractable conditions such as paralysis and blindness.
But the company, founded in 2016, did not seek permission from the FDA until early 2022 – and the agency rejected the application, current and former employees told Reuters in March.
The FDA approval comes as US legislators urged regulators this month to investigate whether the make-up of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.
Neuralink has already been the subject of federal investigations.
The US Department of Agriculture's inspector general was late last year investigating, at the request of a federal prosecutor, possible breaches of the Animal Welfare Act, which governs how researchers treat and test certain types of animals.
The inquiry has also been looking at the USDA's regulation of Neuralink.
In a tweet on Thursday, Neuralink said that the company was not yet open for a clinical trial.
"This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people," the company said in a tweet on Thursday.
Neuralink is developing a brain implant it hopes will help paralysed people to walk again and cure other neurological ailments.
The FDA did not immediately respond to a request for comment.
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Company profile
Name: The Concept
Founders: Yadhushan Mahendran, Maria Sobh and Muhammad Rijal
Based: Abu Dhabi
Founded: 2017
Number of employees: 7
Sector: Aviation and space industry
Funding: $250,000
Future plans: Looking to raise $1 million investment to boost expansion and develop new products
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School counsellors on mental well-being
Schools counsellors in Abu Dhabi have put a number of provisions in place to help support pupils returning to the classroom next week.
Many children will resume in-person lessons for the first time in 10 months and parents previously raised concerns about the long-term effects of distance learning.
Schools leaders and counsellors said extra support will be offered to anyone that needs it. Additionally, heads of years will be on hand to offer advice or coping mechanisms to ease any concerns.
“Anxiety this time round has really spiralled, more so than from the first lockdown at the beginning of the pandemic,” said Priya Mitchell, counsellor at The British School Al Khubairat in Abu Dhabi.
“Some have got used to being at home don’t want to go back, while others are desperate to get back.
“We have seen an increase in depressive symptoms, especially with older pupils, and self-harm is starting younger.
“It is worrying and has taught us how important it is that we prioritise mental well-being.”
Ms Mitchell said she was liaising more with heads of year so they can support and offer advice to pupils if the demand is there.
The school will also carry out mental well-being checks so they can pick up on any behavioural patterns and put interventions in place to help pupils.
At Raha International School, the well-being team has provided parents with assessment surveys to see how they can support students at home to transition back to school.
“They have created a Well-being Resource Bank that parents have access to on information on various domains of mental health for students and families,” a team member said.
“Our pastoral team have been working with students to help ease the transition and reduce anxiety that [pupils] may experience after some have been nearly a year off campus.
"Special secondary tutorial classes have also focused on preparing students for their return; going over new guidelines, expectations and daily schedules.”
