Elon Musk’s brain implant company Neuralink announces FDA approval of in-human clinical study
Neuralink logo displayed on a phone screen, a silhouette of a paper in shape of a human face and a binary code displayed on a screen are seen in this multiple exposure illustration photo taken in Krakow, Poland on December 10, 2021.
Jakub Porzycki | Nurphoto | Getty Images
Neuralink, the neurotech startup co-founded by Elon Musk, announced Thursday it has received approval from the Food and Drug Administration to conduct its first in-human clinical study.
Neuralink is building a brain implant called the Link, which aims to help patients with severe paralysis control external technologies using only neural signals. This means patients with severe degenerative diseases like ALS could eventually regain their ability to communicate with loved ones by moving cursors and typing with their minds.
“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 wrote in a tweet.
The FDA and Neuralink did not immediately respond to CNBC’s request for comment. The extent of the approved trial is not known. Neuralink said in a tweet that patient recruitment for its clinical trial is not open yet.
Neuralink is part of the emerging brain-computer interface, or BCI, industry. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. Neuralink is perhaps the best-known name in the space thanks to the high profile of Musk, who is also the CEO of Tesla, SpaceX and Twitter.
Scientists have been studying BCI technology for decades, and several companies have developed promising systems that they hope to bring to market. But receiving FDA approval for a commercial medical device is no small task — it requires companies to successfully conduct several extremely thorough rounds of testing and data safety collection.
No BCI company has managed to clinch the FDA’s final seal of approval. But by receiving the go-ahead for a study with human patients, Neuralink is one step closer to market.
Neuralink’s BCI will require patients to undergo invasive brain surgery. Its system centers around the Link, a small circular implant that processes and translates neural signals. The Link is connected to a series of thin, flexible threads inserted directly into the brain tissue where they detect neural signals.
Patients with Neuralink devices will learn to control it using the Neuralink app. Patients will then be able to control external mice and keyboards through a Bluetooth connection, according to the company’s website.
The FDA’s approval for an in-human study is a significant win for Neuralink after a series of recent hurdles at the company. In February, the U.S. Department of Transportation confirmed to CNBC that it had opened an investigation into Neuralink for allegedly packaging and transporting contaminated hardware in an unsafe manner. Reuters reported in March that the FDA had rejected Neuralink’s application for human trials, and reportedly outlined “dozens” of issues the company needed to address.
Neuralink has also come under fire from activist groups for its alleged treatment of animals. The Physician’s Committee for Responsible Medicine, which advocates against animal testing, has repeatedly called on Musk to release details about experiments on monkeys that had resulted in internal bleeding, paralysis, chronic infections, seizures, declining psychological health and death.
A representative for PCRM did not immediately respond to CNBC’s request for comment.
In addition to helping patients with paralysis, experts believe BCIs could someday help treat maladies like blindness and mental illness. Musk has expressed his intent for Neuralink to explore these future use cases, as well as potential applications for healthy people.
At a “show and tell” recruitment event late last year, Musk even claimed he plans to someday receive one of Neuralink’s implants himself.
“You could have a Neuralink device implanted right now and you wouldn’t even know,” Musk said at the time. “In fact, in one of these demos, I will.”
Binance lawyers allege SEC Chair Gensler offered to serve as advisor to crypto company in 2019
SEC Chair Gary Gensler mocks putting a gun to his head in response to a “Blazing Saddles” reference by Rep. Emanuel Cleaver, D-Mo., during the House Financial Services Committee hearing titled “Oversight of the Securities and Exchange Commission,” in Rayburn Building on Tuesday, April 18, 2023.
Tom Williams | CQ-Roll Call, Inc. | Getty Images
SEC Chair Gary Gensler, who is in the midst of a hefty crackdown on crypto companies, offered to serve as an advisor to Binance’s parent company in 2019, according to the lawyers for Binance and founder Changpeng Zhao.
Documents filed by the SEC on Wednesday indicate that attorneys from Gibson Dunn and Latham & Watkins, two of Binance’s law firms, allege that Gensler offered to serve as an advisor to the crypto exchange in several March 2019 conversations with Binance executives and Zhao. He eventually met Zhao in Japan for lunch later that month, the filing claims.
At the time, Gensler was teaching at Massachusetts Institute of Technology’s Sloan School of Management. He was appointed head of the SEC in 2021 by President Biden, and over the past year has come down hard on the crypto industry, suing numerous companies for allegedly selling unregistered securities.
Earlier this week, the SEC filed 13 charges against Binance and Zhao, alleging the company failed to register as an exchange and broker-dealer, improperly commingled funds and lacked critical internal controls over its businesses.
Before Gensler started going after Binance, he was trying to cozy up to the company, the lawyers say. The Wall Street Journal previously reported on Gensler and Binance’s relationship, citing internal Binance messages and a person close to the SEC chair. Both suggested that Binance approached Gensler.
In the latest filing, the Gibson and Latham attorneys say that Zhao continued to stay in touch with Gensler after the March meeting. And at the future SEC chair’s request, Zhao sat down for an interview with Gensler as part of a cryptocurrency course he was teaching at MIT.
The SEC on Tuesday described Zhao, who reportedly resides in the UAE, as a “foreign national” with a tendency for “geographic elusiveness.” Zhao’s lawyers now say that the Zhao understood that Gensler was “comfortable serving as an informal advisor.”
Later in 2019, the letter said, Gensler was slated to testify before the House Financial Services Committee, and he sent Zhao a copy of his intended testimony ahead of the hearing.
In July of that year, Gensler testified before the House over Facebook’s proposed and later canceled cryptocurrency Libra and its planned Calibra wallet.
“I do not advise any financial, technology, blockchain or other companies, nor do I own any cryptocurrencies,” Gensler’s prepared testimony read.
Gensler’s advice to lawmakers at the time was largely the same as his public statements today. He said that, with Facebook envisioning a wallet to store customer assets, rules needed to be in place “to guard against Calibra’s use or potential abuse of such customer funds.”
He also testified more broadly in language that’s resembles his latest pronouncements.
“We must guard against illicit activities, such as tax evasion, money laundering, terrorist financing and avoiding sanctions,” he said at the time. “We must protect individuals’ privacy.”
Because of Gensler’s ties to Zhao, Binance’s lawyers said they’d asked for his recusal from any actions regarding the company. They say they got no acknowledgement from SEC staff.
An SEC spokesperson said in a statement to CNBC that, “the Chair is very familiar with and full compliance with his ethical obligations including any recusal obligations.”
The SEC’s probes into Binance.US and Binance began in 2020 and 2021, respectively, well after Gensler and Zhao’s last alleged contact.
Google tells employees in New York and along the East Coast to work from home as smoke fills the air
People ride bicycles at 6th Avenue as haze and smoke caused by wildfires in Canada blanket New York City, New York, June 7, 2023.
Andrew Kelly | Reuters
Google is telling its East Coast employees to stay home as wildfire smoke fills the air in New York and other major cities.
Company site leads in New York wrote in a memo to workers in the area that air quality in many parts of the region had reached “unhealthy” levels, citing the New York state Department of Environmental Conservation. In New York, most employees have been expected to work from physical offices at least three days a week.
“We are advising Googlers to work from home if possible, and limit their exposure to outdoor air,” according to the note, which was obtained by CNBC. “Terraces across our New York campus will remain closed today.”
According to NBC, the company issued advisory notices to workers in the Detroit area, Washington, D.C., Reston, Virginia, Pittsburgh and Raleigh-Durham, North Carolina. In Canada, which is on track to experience its worst-ever wildfire season, Google notified employees in the Ontario cities of Toronto and Waterloo.
New York Mayor Eric Adams issued a statement Wednesday urging all New Yorkers to limit outdoor activity, and airports delayed flights as smoke from Canadian wildfires engulfed surrounding regions.
Google has dealt with this issue in the recent past.
In 2020, the company’s home state of California faced hazardous air quality issues for almost a month as a result of record-setting wildfires that burned across the state. Many people at Google and across the tech industry were already working from home because it was the height of the Covid pandemic.
Google has set up a so-called “go” link that directs employees to internal documents and information about wildfires and air filtering. It released similar resources during the 2020 wildfires. The company typically has “go” links for things like products, employee equipment, office information and some social causes.
The memo on Wednesday advised employees to remain indoors, “avoid vigorous physical activity” and run their air conditioners with clean filters. The site leads assured those who are already working on site that the campuses’ HVAC and air filtration systems “maintain a high quality of air inside our offices even in these circumstances.”
WATCH: FAA pauses all flights into LaGuardia due to limited visibility from smoke
Amazon is pursuing ‘too many ideas’ and needs to focus on best opportunities, analyst says in letter to Jassy
In its quest to upend everything from health care and grocery stores to internet satellites, Amazon has become too unfocused and is missing out on opportunities in its core businesses, according to Bernstein analysts, who on Wednesday published what they called an “open letter” to CEO Andy Jassy and the board.
Amazon remains dominant in e-commerce and cloud computing with Amazon Web Services. In some other areas, however, the company has spent heavily without seeing the results, the analysts said.
“We fully support Amazon’s efforts to uncover and capture the next AWS-sized opportunity,” wrote Bernstein’s Mark Shmulik, who has an outperform rating on the stock. “But what we’ve seen recently is a company simply pursuing too many ideas, with weaker ideas taking away the oxygen, capital, and most importantly focus from the truly disruptive initiatives that ‘only Amazon can do.'”
Amazon’s stock performance compared with its “closest mega-cap peers” — Apple, Microsoft and Google — has also left investors wanting, Shmulik said. Amazon shares are up 50% year to date, but they’ve underperformed top peers by about 52% over a five-year period, he said.
The stock was down 3.6% to $122.12 as of early afternoon New York time.
Shmulik urged Amazon to get back to its “Day One” mentality, referring to a phrase championed by Amazon founder and Executive Chairman Jeff Bezos, who was succeeded by Jassy in July 2021. Bezos famously said a Day One mentality would help Amazon stave off its demise, and described it as continuing to innovate rapidly like a startup, no matter how large the company becomes.
“Day 2 is stasis,” Bezos said in a 2017 shareholder letter. “Followed by irrelevance. Followed by excruciating, painful decline. Followed by death. And that is why it is always Day 1.”
Amazon should “divest, seek outside funding, or trim spend” in health care and its nascent low Earth orbit satellite venture, called Project Kuiper, Shmulik wrote. He pointed to Amazon’s multiyear effort to break into health care, before abandoning efforts like its Care telehealth service, Halo health and fitness band, and a joint health-care venture called Haven.
Kuiper “appears even more extreme as an investment area,” according to Shmulik, with Amazon committing $10 billion to build out the initiative. Google’s lack of success with its Project Loon, Fiber and Fi efforts signals “capital intensive low-margin utilities aren’t worth the effort regardless of how ‘cool’ the technology may be,” he wrote.
Amazon should even take a page out of Alphabet’s book and strip out Kuiper, health care and possibly Alexa into “other bets,” Shmulik said. Doing so, he says, would show a “far healthier and more profitable core business” and wouldn’t detract from the company’s effort to “build the next AWS.”
Shmulik is also skeptical of Amazon’s ongoing efforts to expand in international markets like Brazil, Singapore and India, where competition remains stiff. He calls it a case of throwing “good money after bad,” despite the strategic value that those markets may hold.
When it comes to Whole Foods, Fresh supermarkets and Go cashierless convenience stories, Amazon needs to “make a call on physical grocery,” Shmulik wrote. Amazon bought Whole Foods for $13.7 billion in 2017, and has continued to build out its grocery offerings on its website, while launching other experimental shops. Recently, the company paused further expansion of its Fresh and Go stores as Jassy looks to cut costs.
Instead of continuing to “tinker with” its Fresh and Go stores, Shmulik said Amazon should “purchase a proven concept such as potential divested KR/ACI stores,” referring to the stores Kroger and Albertsons’ are selling off as part of their planned merger.
Amazon should focus on its core strengths and keep pushing into other areas where it’s gained traction, Shmulik said, encouraging a continued build-out of its advertising and media arms, as well as its Buy With Prime service, which allows websites off of Amazon to take advantage of its Prime delivery benefits.
The current scattershot approach is confusing to shareholders and needs to be cleared up to stem continued underperformance, Shmulik added, calling out uncertainty around where Amazon falls in the artificial intelligence race.
“We get investor questions today asking ‘is AWS in last place in AI?’, ‘is retail actually a profitable business?’, and even ‘do we want Andy on the earnings call?'” Shmulik wrote. “It points to one underlying issue: Amazon doesn’t own its own narrative.”
Amazon didn’t immediately respond to a request for comment.
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