Brain-Computer Interface: How an FDA 'Breakthrough Tag' could expedite voice to the mute
The speech restoration device—an AI-driven brain-machine interface designed to assist individuals with severe speech impairments caused by conditions such as stroke, spinal cord injury, amyotrophic lateral sclerosis (ALS), cerebral palsy, and multiple sclerosis—represents a true revolution in healthcare.
Although it was a high-risk endeavor for Noland Arbaugh and Brad Smith when Neuralink, the neurotechnology company founded by Elon Musk in 2016, conducted its human trials of this technology in recent years, the prospect of this technology becoming a widely accessible, high-tech therapy for thousands with speech impairments may not be far off.
Neuralink recently reached a major milestone in its mission to transform healthcare. Last week, the company announced that its speech restoration device had received the US Food and Drug Administration's (FDA) "Breakthrough Device" designation. This recognition, granted under the FDA's Breakthrough Devices Program, is intended to expedite the development and review of medical technologies that offer significant improvements over existing treatments for life-threatening or irreversibly debilitating conditions.
Here's a detailed look at the brain implant's potential to help individuals with severe speech impairments:
What Is A Breakthrough Device
The FDA's Breakthrough Devices Program is designed to expedite the development, assessment, and review of medical devices that can provide significant improvements over current treatment options. The goal is to offer patients and healthcare providers faster access to innovations that could meaningfully improve health outcomes. By granting this designation to Neuralink's speech restoration device, the FDA aims to accelerate the device's journey toward becoming a clinically available treatment for individuals with severe neurological conditions.
This speech restoration device has been specifically designed to assist individuals suffering from severe speech impairments caused by neurological conditions. These conditions include amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other disorders that impact the brain's ability to control speech. For individuals with these conditions, communication can become incredibly difficult, severely limiting their quality of life. The speech restoration device seeks to restore communication abilities by utilizing a brain-computer interface (BCI) that allows users to communicate through neural signals.
The Revolution that Neuralink Technology offers:
Currently there are three key BCI driven healthcare solutions that Neuralink has designed and developed.
N1 Implant:
At the heart of Neuralink's mission is its N1 implant, a small, coin-sized device designed to be implanted in the brain. Equipped with flexible threads containing electrodes, the N1 implant can detect neural activity and transmit these signals to external devices. This allows for direct communication between the brain and the device, bypassing damaged pathways in the brain and nervous system. The device is implanted using a robotic surgical system designed to minimize invasiveness and maximize precision. This technology is central not only to speech restoration but also to other treatments that Neuralink is exploring for neurological conditions.
Blindsight:
Another groundbreaking product from Neuralink is Blindsight, an experimental device aimed at restoring vision in individuals with total visual impairment. Instead of relying on the optic nerve, Blindsight directly stimulates the visual cortex of the brain, bypassing damaged pathways and enabling the brain to create a visual perception. The FDA has also granted Breakthrough Device Designation to Blindsight, highlighting its potential to change the lives of individuals who have lost their sight due to optic nerve damage.
Speech Restoration Device:
The speech restoration device, which earned FDA's Breakthrough Device Designation, is the latest in Neuralink's portfolio. This device aims to assist individuals with speech impairments due to various neurological disorders. The device's development underscores the company's commitment to improving the lives of individuals affected by debilitating conditions.
Clinical Applications and Trials: A New Era in Neurological Care
Neuralink has been actively testing its devices in human clinical trials. In January 2024, Noland Arbaugh became the first human recipient of a Neuralink implant. While the device faced some challenges, including the retraction of implant threads, it enabled Arbaugh to control a computer cursor with his thoughts, demonstrating the potential for BCIs to restore digital autonomy to individuals with paralysis.
In April 2025, Brad Smith, a man paralysed by ALS, became the third recipient of a Neuralink implant. Smith's ability to use the device to type, edit videos, and communicate through brain-controlled cursor movements marked a significant leap forward in restoring the ability to communicate for individuals with severe neurological impairments. This success story illustrates how BCIs can dramatically improve the quality of life for people with disabilities, giving them a voice when traditional methods of communication are no longer viable.
Ethical Considerations and Challenges
As promising as Neuralink's technology is, it raises a host of ethical and technical questions. Some of the most pressing concerns include:
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Hindustan Times
a minute ago
- Hindustan Times
Merge Labs aims to take on Neuralink with support from Sam Altman
OpenAI's CEO, Sam Altman, is reportedly planning to back a new company called Merge Labs that works on brain-computer technology. This tech lets the brain connect directly with computers. This new startup is expected to compete directly with Elon Musk's Neuralink, founded in 2016. Merge Labs aims to revolutionise brain-computer tech with support from OpenAI's Sam Altman.(AFP File) Neuralink has been working on brain implants since 2016 to help people with paralysis control devices with their thoughts. Merge Labs reportedly wants to go even further and the idea is to make the connection between humans and AI smoother and maybe even enhance human abilities beyond just medical needs. Merge Labs is still at a very early stage and is aiming for a valuation of about 850 million dollars and seeking 250 million dollars in funding. The money may come from OpenAI's investment arm. Sam Altman is also teaming up with Alex Blania who is working on another project focused on advanced biometrics for identity verification. There is one big difference between Neuralink and Merge Labs: Merge Labs is exploring less invasive brain implants, the ones that will not require major surgery and will make heavy use of artificial intelligence to improve how the technology works. Neuralink has already tested its implants in humans and reached a nine billion dollar valuation. The brain-computer interface field is making rapid progress. Recently, at the 2025 World Robot Championship in Beijing, teams demonstrated brain-controlled robots and drones that respond to brain signals in real time. In another breakthrough, scientists at UC Davis created a brain-computer system that turns brain signals into speech for a man with ALS giving him the ability to talk. This kind of technology can change rehabilitation, assistive tools and even make home automation easy through natural human-computer interaction. These innovations show that brain-computer technology is finally leaving the labs and moving toward real-world use and has the potential to help millions of people.
Hindustan Times
3 hours ago
- Hindustan Times
Doctor shares 10 daily foods that mimic Ozempic and make weight loss easier
Ozempic is not just a celebrity buzzword! It is a prescription drug originally developed to treat type 2 diabetes, now widely talked about for its surprising weight loss effects. This buzz has sparked curiosity about whether there are natural alternatives to Ozempic. The answer is yes! Dr Adrian, a functional medicine doctor and MD specializing in thyroid, PCOS, and gut health, recently shared on Instagram a list of foods that may work in a similar way. These foods can help boost GLP-1, the hormone that curbs unnecessary hunger and helps control appetite, supporting a healthy weight loss. Try these foods to naturally boost GLP-1 levels! (Adobe Stock) What is Ozempic? Ozempic is the brand name for semaglutide, a medication created by Danish drugmaker Novo Nordisk. It belongs to a class of drugs called GLP-1 receptor agonists, meaning it imitates the effects of a hormone your body naturally produces, GLP-1. First approved by the US Food and Drug Administration in 2017 for managing type 2 diabetes, Ozempic comes as a once-weekly injection, usually given in the abdomen, thigh, or upper arm using a prefilled pen. How does GLP-1 support weight loss? GLP-1 is an incretin hormone released in your gut after you eat. Health Shots also got in touch with dietitian Vidhi Chawla to learn more about it. She says, 'It triggers more insulin, curbs glucagon (which raises blood sugar), and slows digestion, all of which help keep blood sugar stable and reduce appetite.' That is why Ozempic is effective for weight loss. Foods to boost GLP-1 Here are 10 foods that may help make weight loss feel easier and quicker with an Ozempic prescription: 1. Avocados Packed with healthy monounsaturated fats and fibre, avocados keep hunger hormones in check. Dr Adrian notes that their slow-digesting fat content supports steady blood sugar, while the fibre helps keep you feeling full for longer. A study published in Nutrients revealed that eating a whole avocado can boost GLP-1 levels, along with reducing cravings and appetite. This food is also rich in potassium, which supports metabolism and slows down digestion. 2. Chia seeds These tiny seeds are a powerhouse of soluble fibre. When soaked, they form a gel in your stomach that slows digestion, much like Ozempic delays gastric emptying (the rate at which food moves from the stomach to the small intestine). Vidhi Chawla adds that chia seeds are also a good plant-based omega-3 source, supporting gut health and reducing inflammation linked to weight gain. 3. Potatoes Often misunderstood, potatoes (especially boiled or baked) are among the most satiating foods that can support weight loss. They provide slow-digesting carbs that keep energy stable. Dr Adrian points out that their resistant starch content feeds beneficial gut bacteria, which may indirectly support weight control. 4. Oats Oats, particularly rolled oats, are rich in beta-glucan, a soluble fibre that triggers fullness hormones. They are a steady energy source that reduces the risk of unwanted hunger. Vidhi recommends starting your day with oatmeal paired with protein, like Greek yogurt, for even better hunger control. According to her, fibre rich foods help reduce your calorie intake by promoting the feeling of fullness. Oats can support weight loss!(Adobe Stock) 5. Eggs and egg whites Eggs are loaded with protein that lowers ghrelin, the "I'm hungry" hormone. Their amino acids also support muscle maintenance during weight loss. Having them at breakfast can help curb appetite for hours, making them a simple yet effective tool in any weight-loss-friendly diet. So, make sure you start your day with a protein and fibre-rich breakfast to support weight loss. 6. Greek Yogurt Thick, creamy, and protein-rich, Greek yogurt is digested slowly, keeping you satisfied for longer. Its probiotic content supports gut health, which is linked to better weight management. Dr Adrian advises choosing unsweetened versions to avoid unnecessary sugar spikes. 7. Lean meat From skinless chicken to turkey, lean meats deliver high-quality protein that boosts metabolism due to the thermic effect of food. This means you burn more calories even when digesting food. Vidhi notes that protein also helps prevent the muscle loss often seen in rapid weight loss, keeping metabolism healthy. 8. Fish Fatty fish like salmon, mackerel, and sardines offer both protein and omega-3 fats. Dr Adrian says this combo reduces inflammation, balances hormones, and suppresses appetite. Eating fish 2–3 times a week can be a game-changer for promoting both satiety and metabolic health. 9. Berries Low in sugar but high in fibre, berries are ideal for controlling blood sugar spikes. Their antioxidants also help reduce inflammation, which can interfere with hunger and satiety signals. Vidhi suggests pairing berries with Greek yogurt for a balanced, filling snack. 10. Leafy greens Spinach, kale, broccoli, and other fibre-rich vegetables are filling yet low in calories. They fill your stomach, stimulate fullness hormones, and deliver vitamins that support overall metabolic function, explains Dr Adrian. One 2022 study published in the International Journal of Preventive Medicine found that eating vegetables before carbohydrates significantly improves glucose and GLP-1 levels in people with type 2 diabetes. What's more? Since they are also high in vitamins, minerals, and antioxidants, they can also help support healthy metabolism and the fat-burning process.
Time of India
5 hours ago
- Time of India
How a one-minute jolt can offer hope to those with auto-immune disease
The US Food and Drug Administration (FDA) approved a medical device recently that offers new hope to patients incapacitated by rheumatoid arthritis (RA), a chronic condition often resistant to treatment and usually managed with medications. The device represents a radical departure from standard care, tapping the power of the brain and nervous system to tamp down the uncontrolled inflammation that leads to the debilitating autoimmune disease. The SetPoint System is an inch-long device surgically implanted into the neck, where it sits in a pod wrapped around the vagus nerve, which some scientists believe is the longest nerve in the body. The device electrically stimulates the nerve for one minute each day. The stimulation can turn off crippling inflammation and 'reset' the immune system, research has shown. Most drugs used to treat rheumatoid arthritis suppress the immune system, leaving patients vulnerable to serious infections. On a recent episode of the American College of Rheumatology podcast, the SetPoint implant was described as a 'true paradigm shift' in treatment of the disease, which until now has relied almost entirely on an evolving set of pharmaceutical interventions, from gold salts to biologics. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like No annual fees for life UnionBank Credit Card Apply Now Undo The FDA designated the implant as a breakthrough last year to expedite its development and approval. It represents an early test of the promise of so-called bioelectronic medicine to modulate inflammation, which plays a key role in diseases including diabetes, heart disease and cancer. Clinical trials are already underway testing vagus nerve stimulation to manage inflammatory bowel disease in children, lupus and other conditions. Trials for patients with multiple sclerosis and Crohn's disease are also planned. In a yearlong randomised controlled trial of 242 patients that included a sham-treatment arm, over half of the participants using the SetPoint implant alone achieved remission or saw their disease recede. Measures of joint pain and swelling fell by 60% and 63% respectively. The device's long-term effectiveness and safety outside a clinical trial are not yet known. The FDA required post-marketing monitoring of patients and adverse events as part of the approval. Surgery involving implants can lead to serious infections resistant to antibiotics, experts noted. For Dawn Steiner, 58, a speech pathologist, who participated in the clinical trial, the implant has been a game changer. She was diagnosed with rheumatoid arthritis 15 years ago and has tried eight different biologic agents since then. 'Before the implant, the doctor would ask where I was in terms of pain on a scale of one to 10, and I would say I was living a six or seven,' she said. 'Now I'm about a two.' The SetPoint device is the product of decades of research spearheaded by Dr Kevin J Tracey, a neurosurgeon who is president and chief executive of the Feinstein Institutes for Medical Research at Northwell Health. Tracey co-founded SetPoint Medical, but now serves as an adviser. He describes the vagus nerve, which originates in the brain and travels to virtually all the organs of the body, as an 'on-off switch' for an overactive immune system. 'The brain can turn off inflammation as long as the vagus nerve is intact,' he said. 'It's like a brake system in your car.' Dr David Chernoff, chief medical officer of SetPoint Medical, said, 'Drugs find a pathway that contributes to damaging joints in RA patients and try to block it. What we're doing is completely different. We're re-educating the immune system through the brain to behave differently,' he added. As a result, he said, 'we're not blocking the ability to fight off infection.' The body needs some level of inflammation, Tracey said, to help heal wounds, fight infections and promote tissue repair. The price has not been disclosed, but a spokeswoman said it was designed to last for 10 years and would be less expensive than a year's worth of some rheumatoid arthritis drugs, which can be quite costly. One key question is whether the implant's effectiveness will wane over time, said Dr Lou Bridges, chief of the division of rheumatology at the Hospital for Special Surgery and NewYork-Presbyterian/Weill Cornell Medical Center. 'It's still early days. The proof will be in the pudding,' he said. 'I'm hoping they are correct, and this is a revolutionary new way to treat RA without drugs and without side effects. But I've heard this story before. ' nyt news service By: Dr David Chernoff, CMO, SetPoint Medical
