Technology

Neuralink competitor Paradromics gets one step closer to FDA approval for its brain implant

Published

2 years ago

May 18, 2023

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Paradromics Cortical Module

Source: Padromics

A growing team of nearly 50 employees at the neurotech startup Paradromics is working on a brain implant that sounds like the work of science fiction. And it has caught the attention of federal regulators.

Paradromics, founded in 2015, is developing a device that could help patients with severe paralysis regain their ability to communicate by deciphering their neural signals. And on Thursday, the Austin, Texas-based company announced that it has received the Breakthrough Device designation from the Food and Drug Administration for its flagship system, called the Connexus Direct Data Interface.

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CEO Matt Angle said the designation, in addition to a $33 million funding round the company also announced Thursday, will help Paradromics bring its device to market.

Paradromics 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. Experts believe the systems could someday help treat maladies like blindness and mental illness.

Perhaps the best-known name in the space is Neuralink, thanks to the high profile of its co-founder Elon 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.

As of May, no BCI company has managed to clinch the FDA’s final seal of approval.

Paradromics’ BCI, the Connexus Direct Data Interface, is an assistive communication device that translates neural signals into text or synthesized speech. An array of tiny electrodes is implanted directly into the brain tissue, where it measures and deciphers brain signals that are ultimately emitted to external devices through a transceiver that sits under the skin in the chest.

“It’s essentially taking some of the things that have been successful in previous clinical trials, and then improving on them from an engineering standpoint to make them better,” Angle told CNBC in an interview.

Paradromics scientists at work

Source: Paradromics

Angle said the company’s BCI is designed to last around 10 years and will initially be used to help patients who have lost their ability to physically communicate. The device will require invasive brain surgery, but Angle said the quality of the neural signals it can measure will allow patients to communicate at a faster and more natural rate than they could with a less invasive BCI, like the one being developed by Paradromics competitor Synchron.

So far, regulators seem to be on board with Paradromics’ approach. The FDA’s Breakthrough Device designation is granted to medical devices that have the potential to provide improved treatment for debilitating or life-threatening conditions.

The agency has granted 32 of these designations in fiscal 2023 so far, according to its website.

Angle said the designation will help create a “fast track” for communication between the FDA and Paradromics. It’s an advantage that could be key for getting regulators to more quickly approve future clinical trials.

The company is currently conducting animal safety trials, and the data from those trials will help the FDA determine whether to approve an in-human study. Angle said Paradromics is hoping to launch its first clinical trial with human patients in the first half of 2024.

The startup’s new $33 million funding round was led by Prime Movers Lab.

“It’s a beautiful story,” Prime Movers Lab founder and general partner Dakin Sloss told CNBC in an interview. “And it’s a real technology that’s working now, today. It’s not like a pipe dream that you gotta wait 10 years for.”

Angle said it is an exciting time in the BCI field, especially as multiple companies are working to distinguish themselves in an industry that he estimates will create billions of dollars in value. But while it is easy to get excited about the future capabilities of BCIs, Angle believes a lot of good can already be done.

“A lot of people are excited about the futuristic, kind of speculative applications. But the reality of brain-computer interfaces is, in some ways, more exciting,” he said. “It can transform what would otherwise be really challenging problems in brain health.”

Technology

We’re increasing our Cisco Systems price target after an AI-fueled beat and raise

Published

7 hours ago

November 13, 2025

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Technology

CNBC Daily Open: An AI and ‘everything else’ market in play in the U.S.

Published

7 hours ago

November 13, 2025

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CNBC Daily Open: An AI and 'everything else' market in play in the U.S.

Traders work on the floor of the New York Stock Exchange (NYSE) on Nov. 12, 2025 in New York City.

Spencer Platt | Getty Images

The divergence between the performance of the Dow Jones Industrial Average and Nasdaq Composite on Wednesday stateside reinforces the suggestion that there are two markets operating in the U.S.: one of an artificial intelligence and another of “everything else.”

Not only did the Dow rise, it also secured its second consecutive record high and closed above the 48,000 level for the first time.

The index, which comprises 30 blue-chip companies, is typically seen as a marker of the “old economy.” That is to say, it is mostly made up of large, well-established companies driving the U.S. economy, such as banks, healthcare and industrials, before Silicon Valley became a mini sun powering everything.

And it was those stocks — Goldman Sachs, Eli Lilly and Caterpillar — that lifted the Dow on Wednesday.

To be sure, new and flashy names, such as Nvidia and Salesforce, constitute the Dow too. But as the index is price-weighted, meaning that companies with higher share prices influence the Dow more, tech companies don’t exert as much gravity on it.

That’s in contrast to the Nasdaq, which is weighted by companies’ market capitalization, and dominated mainly by technology firms. The tech-heavy index fell as shares like Oracle and Palantir slipped — even Advanced Micro Devices’ 9% pop on its growth prospects couldn’t rescue the Nasdaq from the red.

It’s not necessarily a warning sign about overexuberance in AI.

“There’s nothing wrong, in our view, of kind of trimming back, taking some gains and re-diversifying across other spots in the equity markets,” said Josh Chastant, portfolio manager of public investments at GuideStone Fund.

But what investors would really like is if fork in the road merges into one. That tends to be the safer path to take.

What you need to know today

The Dow Jones Industrial Average notches record. The 30-stock index climbed 0.68% Wednesday stateside to close above 48,000 for the first time. The S&P 500 was mostly flat and the Nasdaq Composite fell 0.26%. The pan-European Stoxx 600 gained 0.71%.

Anthropic to spend $50 billion on U.S. AI infrastructure. Custom data centers will be first built in Texas and New York and go live in 2026, with more locations to follow. The facilities will be developed with Fluidstack, an AI cloud platform.

U.S. October jobs and inflation data might not be released. White House press secretary Karoline Leavitt told reporters that part of the fallout of the government closure could be lasting damage to the government’s data collection ability. But analysts think otherwise.

U.S. House of Representatives heading toward a vote. The House on Wednesday night stateside cleared a procedural hurdle required before the vote could begin on a bill that would end the government shutdown. Voting is expected to happen as of publication time.

[PRO] This U.S. mining stock is a top play: CIO. U.K. fund Blue Whale Capital’s Stephen Yiu said macroeconomic concerns, such as the U.S. fiscal deficit and the weakness of the dollar, could support the stock.

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People walk by the New York Stock Exchange (NYSE) on June 18, 2024 in New York City.

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Why private equity is stuck with ‘zombie companies’ it can’t sell

Private equity firms are facing a new reality: a growing crop of companies that can neither thrive nor die, lingering in portfolios like the undead.

These so-called “zombie companies” refer to businesses that aren’t growing, barely generate enough cash to service debt and are unable to attract buyers even at a discount. They are usually trapped on a fund’s balance sheet beyond its expected holding period.

— Lee Ying Shan

Technology

Firefly Aerospace shares jump 15% on strong revenues, boosted guidance

Published

10 hours ago

November 12, 2025

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Firefly Aerospace shares jump 15% on strong revenues, boosted guidance

Jason Kim, chief executive officer of Firefly Aerospace, center, during the company’s initial public offering at the Nasdaq MarketSite in New York, US, on Thursday, Aug. 7, 2025.

Michael Nagle | Bloomberg | Getty Images

Firefly Aerospace‘s stock surged 15% on Wednesday after the space technology company issued better-than-expected third-quarter results and lifted its guidance.

Revenues in the third quarter jumped nearly 38% to $30.8 million from $22.4 million in the year-ago period and nearly doubled from the previous quarter.

Firefly’s net loss totaled $140.4 million, or $1.50 per share. The company said net loss included costs tied to its IPO, foreign exchange and executive severance

The company also lifted its outlook for the year, saying it now expects revenues to range between $150 million and $158 million. That’s up from previous guidance in the range of $133 million and $145 million.

This is Firefly’s second quarterly report as a public company. Last quarter, shares slumped after it posted a bigger loss and lower revenues than analysts were expecting.

The Cedar Park, Texas, company went public on the Nasdaq in August during a period of heightened enthusiasm toward space technology. The U.S. government and NASA have leaned on more contracts with companies like Firefly and Elon Musk‘s SpaceX to support moon missions.

But shares of Firefly have lost 70% of their value since their opening day close, and the company’s market capitalization has plummeted from about $8.5 billion to about $2.7 billion on Wednesday.

In September, Firefly shares sank after a rocket exploded during a ground test at the company’s Texas facility, days after receiving clearance from the Federal Aviation Administration over a separate incident. Firefly has since put “corrective measures” in place, the company said on Wednesday. Shares dropped 35% in September and are down 24% this month.

Firefly in July won a nearly $177 million contract with NASA for an upcoming moon mission, and in October, it announced its acquisition of defense tech firm SciTec to boost its national security portfolio.