Smart Money: The Move to Make After Musk’s Device Scores “Breakthrough” Status

Here's what the FDA's recent update means…

September 25, 2024 Eric Fry Editor, Smart Money Daily Issue The Move to Make After Musk's Device Scores "Breakthrough" Status Hello, Reader. Before we dive into today’s Smart Money, I first want to thank those of you who joined me and my special guest for last night’s special event. During that video conversation, we discussed… A series of steps you can take to protect your portfolio from the risk of devastating losses, without buying or selling any new investments… How you can get the chance to drastically outperform the market… And how to use my guest’s alert system to potentially take advantage of big melt-ups… and sidestep major crashes. In case you missed it, you can watch a replay of the event here. Now, autumn got started on Sunday, which means that “spooky season” is right around the corner… and what better way to kick off the season than with news from Neuralink, Elon Musk’s neurotechnology company that is creating otherworldly AI devices. Last Tuesday, Neuralink’s brain-computer interface (BCI) device “Blindsight” received the U.S. Food and Drug Administration’s “breakthrough device” designation. Blindsight aims at restoring vision, including in patients “who have lost both eyes and their optic nerve,” according to Musk. Before we get to what that news means, it’s worth reviewing the company’s history again… Musk’s first human clinical trial at Neuralink is called PRIME. That stands for “Precise Robotically Implanted Brain-Computer Interface.” Neuralink’s wireless brain chip, the “N1,” has more than 1,000 electrodes attached to 64 threads, which amplifies its brain-reading potential. Because the N1 threads are thinner than human hairs, they can’t be inserted by hand. But Neuralink’s “R1” surgeon-like robot can target specific parts of the brain and insert all 64 threads – in only about 15 minutes! Once implanted in the brain, the N1 threads interpret a person’s neural activity and make it available for computers. Then, the person can control external devices with their mind, alone. The N1 aims at restoring autonomy to people with “quadriplegia due to spinal cord injury (SCI) or amyotrophic lateral sclerosis (ALS),” a function that the company dubs “telepathy.” Musk’s team at Neuralink successfully implanted the device in their first patient in January of this year… and reported a second successful implantation just last month. Now that we’ve reviewed current strange, fantastical devices, let’s take a look at exactly what the FDA “breakthrough device” designation means… and what it means for Neuralink. Then, I’ll share some ideas on how to profit from the company’s continued success… SPONSORED Replay Now Available: Eric Just Dropped a Bombshell Eric Fry just dropped a bombshell on his readers. He said the markets could soon experience a violent crash and shared a unique way you can determine the day the next crash will happen. Watch the replay here. Neuralink Is Breaking Through The FDA awards its “breakthrough device” tag to in-development medical devices that show potential for treating serious or life-threatening conditions. It is intended to speed the development and review process. Neuralink had previously received two similar FDA approvals for testing its N1 and R1 PRIME devices in humans. The FDA made these approvals based on several criteria that the patients had to meet, including being at least 22 years old, having quadriplegia and limited function in all four limbs, and having at least one year post-injury without improvement. The FDA’s newest “breakthrough” device designation for Neuralink will now speed up the approval process for Blindsight, potentially leading to human trials. Now, this designation does not guarantee that a new medical device will be successful… or even that it will work at all and be allowed on the market. Between 2015 through 2021, the FDA granted such “breakthrough” status for 617 devices, but only 13 received marketing authorization. Still, this approval suggests the FDA is more open to Neuralink – and its PRIME and Blindsight devices – than its critics realize. Neuralink must have provided evidence that Blindsight meets the FDA’s first criterion for eligibility, providing “more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions,” and one of a second set of criteria, including representing “breakthrough technology.” Getting In on This Wealth Creator Neuralink has not yet provided details about when it expects the Blindsight device to move into human trials. However, looking ahead, Musk revealed that the team at Neuralink is working on an improved AI device that could potentially “double the bandwidth” of its current N1 model. He hopes that the number of implanted devices reaches the “high single digits” by the end of this year. So, with a longer-term goal of more or less fusing human and artificial intelligence, Neuralink’s devices could take their place alongside PCs and smartphones as one of the biggest wealth creators in history. That means we want to find a way to get in on it. Now, Neuralink is still a private company… but that doesn’t mean there aren’t ways for investors to profit from its success. One well-known tech company, in particular, can give investors some exposure to Neuralink’s growth. I put all the details inside How to Profit From Elon Musk’s Neuralink at my Fry’s Investment Report service. To get access to this special report – and the stock recommendation inside – learn how to join me at my Fry’s Investment Report today. Regards, Eric Fry Editor,Smart Money P.S. We've seen chaos in the markets ever since 2020... And despite the relief of last past week’s rate cuts, several headwinds – wars in the Middle East and Ukraine, the election, and more – are still swirling around the markets. That's why, last night, my special guest and I sat down to talk about some tools investors can use to prepare their portfolios for whatever comes next. Click here to watch our conversation now.

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