Latest news with #BreakthroughDeviceDesignation
Yahoo
6 hours ago
- Business
- Yahoo
Musk's Neuralink Secures $650 Million for Clinical Push
Neuralink just closed a hefty $650 million Series E round, pushing its valuation past the $9 billion mark. Backed by big names like ARK Invest, Founders Fund, Sequoia Capital, QIA and Valor Equity Partners, this infusion makes it clear that investors still believe in Tesla (NASDAQ:TSLA) CEO Elon Musk's vision of braincomputer interfaces (BCIs). In more concrete terms, it means Neuralink can accelerate its clinical trialsright now, five patients with severe paralysis are already using implanted devices to control computers and smartphones with their thoughts alone. Those trials span institutions like the Barrow Neurological Institute, Miami Project to Cure Paralysis, Toronto Western Hospital and the Cleveland Clinic in Abu Dhabi. And because Neuralink is hoping to snag Breakthrough Device Designation from the FDA for its vision and speech restoration program, the clock is tickingdecisions on that usually land within 60 days. If they get it, the path to wider use becomes a lot smoother. Of course, this isn't just about bolstering medical trials. With the new capital, Neuralink can beef up manufacturing and expand its engineering teamscritical steps if it's going to compete in an emerging market for neuroprosthetics. Moreover, thanks to Musk's broader ecosystem commitment with Tesla, SpaceX, Starlink, xAI and XNeuralink has unique access to AI expertise, hardware know-how and regulatory resources. All told, the big raise and the early patient wins suggest Neuralink's bets on restoring autonomy to people with paralysis (and possibly beyond) are far from over. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data
Yahoo
6 hours ago
- Business
- Yahoo
Musk's Neuralink Secures $650 Million for Clinical Push
Neuralink just closed a hefty $650 million Series E round, pushing its valuation past the $9 billion mark. Backed by big names like ARK Invest, Founders Fund, Sequoia Capital, QIA and Valor Equity Partners, this infusion makes it clear that investors still believe in Tesla (NASDAQ:TSLA) CEO Elon Musk's vision of braincomputer interfaces (BCIs). In more concrete terms, it means Neuralink can accelerate its clinical trialsright now, five patients with severe paralysis are already using implanted devices to control computers and smartphones with their thoughts alone. Those trials span institutions like the Barrow Neurological Institute, Miami Project to Cure Paralysis, Toronto Western Hospital and the Cleveland Clinic in Abu Dhabi. And because Neuralink is hoping to snag Breakthrough Device Designation from the FDA for its vision and speech restoration program, the clock is tickingdecisions on that usually land within 60 days. If they get it, the path to wider use becomes a lot smoother. Of course, this isn't just about bolstering medical trials. With the new capital, Neuralink can beef up manufacturing and expand its engineering teamscritical steps if it's going to compete in an emerging market for neuroprosthetics. Moreover, thanks to Musk's broader ecosystem commitment with Tesla, SpaceX, Starlink, xAI and XNeuralink has unique access to AI expertise, hardware know-how and regulatory resources. All told, the big raise and the early patient wins suggest Neuralink's bets on restoring autonomy to people with paralysis (and possibly beyond) are far from over. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
4 days ago
- Business
- Yahoo
BiVACOR's Total Artificial Heart Receives FDA Breakthrough Device Designation
Clinical-stage company earns key regulatory milestone as it advances a first-of-its-kind heart replacement system toward wider use. HUNTINGTON BEACH, Calif., May 30, 2025--(BUSINESS WIRE)--BiVACOR, a clinical-stage medical device company developing the world's first titanium Total Artificial Heart (TAH), today announced that its device has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The designation supports the BiVACOR TAH as a bridge to transplant (BTT) for adults with severe biventricular or univentricular heart failure where current treatments, including LVADs, are not viable. The FDA's Breakthrough Device program is reserved for technologies that may significantly improve outcomes for patients with life-threatening or irreversibly debilitating conditions. It offers priority regulatory interaction and accelerated pathways to approval. "This is more than a regulatory milestone. It's a validation of a concept we've spent decades proving that a fully implantable, total artificial heart isn't just possible, it's necessary," said Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR. "Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies. The Breakthrough Device Designation puts us on a faster track to deliver exactly that." The milestone follows the first phase of BiVACOR's FDA Early Feasibility Study, where five patients in the U.S. received the TAH between July and November 2024. Based on positive safety and performance data, the FDA approved the expansion of the trial to include 15 additional patients starting later this year. BiVACOR's device represents a new category in artificial heart technology. Compact enough to fit most men and women, the TAH uses magnetic levitation, similar to maglev trains, to suspend a single dual-sided rotor. This rotor simultaneously powers the right and left circulatory systems, mimicking the natural heartbeat without valves or mechanical wear points. Its simplified design allows for pulsatile flow, large blood gaps to reduce trauma, and long-term durability. "We've seen every kind of artificial heart technology over the last four decades, but this is the first system I've encountered that combines engineering elegance, efficiency, and safety with true clinical viability," said William Cohn, MD, BiVACOR Chief Medical Officer and heart surgeon at the Texas Heart Institute. "The early results are remarkable with no strokes, no device-related complications, and a safety profile unlike anything in this space. With Breakthrough status in hand, we're entering the next phase with the wind at our backs and real momentum to bring this to more patients." Heart failure affects more than 6 million Americans, and thousands of patients each year progress to irreversible biventricular failure. However, the number of available donor hearts remains stagnant, with fewer than 4,500 transplants performed annually in the U.S. BiVACOR is targeting this critical gap with a durable artificial replacement engineered for eventual long-term support. The BiVACOR TAH is currently investigational and not approved for commercial use. About BiVACOR BiVACOR® is a clinical-stage medical device company developing a fully implantable, magnetically levitated Total Artificial Heart for long-term support of patients with end-stage biventricular heart failure. Founded by biomedical engineer Daniel Timms, PhD, and backed by leading experts in cardiovascular medicine including Dr. William E. Cohn and Dr. O.H. (Bud) Frazier, the company is conducting an FDA-approved Early Feasibility Study in the U.S. Headquartered in Huntington Beach, CA, with clinical operations in Houston and engineering offices in Gold Coast, Australia, BiVACOR is committed to addressing the global shortage of donor hearts through advanced, scalable technology. Learn more at View source version on Contacts Media Contact: Dana SummersPenman PRdana@
Business Wire
4 days ago
- Business
- Business Wire
BiVACOR's Total Artificial Heart Receives FDA Breakthrough Device Designation
HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--BiVACOR, a clinical-stage medical device company developing the world's first titanium Total Artificial Heart (TAH), today announced that its device has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). 'This is more than a regulatory milestone. It's a validation of a concept we've spent decades proving that a fully implantable, total artificial heart isn't just possible, it's necessary,' said Daniel Timms, PhD, Founder and CTO of BiVACOR Share The designation supports the BiVACOR TAH as a bridge to transplant (BTT) for adults with severe biventricular or univentricular heart failure where current treatments, including LVADs, are not viable. The FDA's Breakthrough Device program is reserved for technologies that may significantly improve outcomes for patients with life-threatening or irreversibly debilitating conditions. It offers priority regulatory interaction and accelerated pathways to approval. 'This is more than a regulatory milestone. It's a validation of a concept we've spent decades proving that a fully implantable, total artificial heart isn't just possible, it's necessary,' said Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR. 'Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies. The Breakthrough Device Designation puts us on a faster track to deliver exactly that.' The milestone follows the first phase of BiVACOR's FDA Early Feasibility Study, where five patients in the U.S. received the TAH between July and November 2024. Based on positive safety and performance data, the FDA approved the expansion of the trial to include 15 additional patients starting later this year. BiVACOR's device represents a new category in artificial heart technology. Compact enough to fit most men and women, the TAH uses magnetic levitation, similar to maglev trains, to suspend a single dual-sided rotor. This rotor simultaneously powers the right and left circulatory systems, mimicking the natural heartbeat without valves or mechanical wear points. Its simplified design allows for pulsatile flow, large blood gaps to reduce trauma, and long-term durability. 'We've seen every kind of artificial heart technology over the last four decades, but this is the first system I've encountered that combines engineering elegance, efficiency, and safety with true clinical viability,' said William Cohn, MD, BiVACOR Chief Medical Officer and heart surgeon at the Texas Heart Institute. 'The early results are remarkable with no strokes, no device-related complications, and a safety profile unlike anything in this space. With Breakthrough status in hand, we're entering the next phase with the wind at our backs and real momentum to bring this to more patients.' Heart failure affects more than 6 million Americans, and thousands of patients each year progress to irreversible biventricular failure. However, the number of available donor hearts remains stagnant, with fewer than 4,500 transplants performed annually in the U.S. BiVACOR is targeting this critical gap with a durable artificial replacement engineered for eventual long-term support. The BiVACOR TAH is currently investigational and not approved for commercial use. About BiVACOR BiVACOR® is a clinical-stage medical device company developing a fully implantable, magnetically levitated Total Artificial Heart for long-term support of patients with end-stage biventricular heart failure. Founded by biomedical engineer Daniel Timms, PhD, and backed by leading experts in cardiovascular medicine including Dr. William E. Cohn and Dr. O.H. (Bud) Frazier, the company is conducting an FDA-approved Early Feasibility Study in the U.S. Headquartered in Huntington Beach, CA, with clinical operations in Houston and engineering offices in Gold Coast, Australia, BiVACOR is committed to addressing the global shortage of donor hearts through advanced, scalable technology. Learn more at
Yahoo
19-05-2025
- Health
- Yahoo
Gradient Denervation Technologies Announces FDA Breakthrough Designation for Pulmonary Artery Denervation System
PARIS, May 19, 2025 (GLOBE NEWSWIRE) -- Gradient Denervation Technologies announced today the company's pulmonary denervation system has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This program creates an expedited review pathway for devices that have the potential to provide more effective treatment for life-threatening or debilitating conditions and meet FDA's rigorous standards for safety and efficacy. The Gradient Denervation System is a novel technology intended to treat patients with pulmonary hypertension and associated heart failure. Treatment is accomplished by ablating nerves around the pulmonary artery using therapeutic ultrasound energy in a minimally invasive, percutaneous procedure. The straightforward catheter platform was designed specifically for the pulmonary artery anatomy and leverages known interventional techniques. The treatment goal is to down-regulate the sympathetic activity in the pulmonary vascular tree to reduce vascular resistance and decrease pulmonary pressures. The PreVail-PH2 Early Feasibility Study is enrolling patients with pulmonary hypertension due to left-sided heart disease, classified by the World Health Organization (WHO) as Group 2 Pulmonary Hypertension. As many as two-thirds of heart failure patients around the world have elevated pulmonary vascular resistance, which is shown to lead to an increased risk of mortality and hospitalization. There are no approved drug or device therapies in the United States for this group of pulmonary hypertension patients. 'We are thrilled with this positive feedback from FDA. The granting of Breakthrough Device Designation marks another important milestone for our pulmonary denervation clinical development program,' said Martin Grasse, Chief Executive Officer of Gradient. 'We remain focused on completion of our early feasibility study as a crucial first step toward developing a targeted treatment option with the potential to improve outcomes and quality of life for these underserved patients.' About Gradient Denervation TechnologiesGradient Denervation Technologies is a Paris-based medical device company developing a minimally invasive, ultrasound-based device for the treatment of pulmonary hypertension. Gradient leverages intellectual property developed at Stanford University. The Gradient Denervation System is for investigational use only and is not approved for commercial use. For more information, please visit: CONTACT: Media Contact info@ in to access your portfolio
