The Latest Cardiac and Vascular News
CHICAGO–(BUSINESS WIRE)–GE HealthCare (Nasdaq: GEHC) today announced the intent to establish a collaborative research network focused on advancing neuroscience research leveraging an ultra high-gradient head-only 3.0T MR system1. The MAGNUS2 Neuro Alliance will bring together researchers and clinicians with expertise in neurology, radiology, psychiatry, oncology, and several other subject areas, to explore how high-performance MR imaging may enable new scientific questions and research approa
WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer Bayer’s SUNHARBO® (asundexian), 50 mg tablets, the First and Only Factor XIa Inhibitor, Approved by the U.S. FDA to Reduce the Risk of Stroke in Adults With Recent Non-Cardioembolic Ischemic Stroke or High-Risk Transient Ischemic Attack, in Combination With Antiplatelet Therapy Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved SUNHARBO® (asundexian), 50 mg tablets, a first-in-class, once daily, Factor XIa inhibitor indicat
AI-powered analysis of Phase 3 CHARM trial suggests that Brainomix non-contrast CT (NCCT) technology may help identify severe stroke patients more likely to benefit from CIRARA, supporting more precise patient selection and the design of future stroke trials. Data presented at the 18th…
SARASOTA, Fla. & AUSTIN, Texas–(BUSINESS WIRE)–Deep Reasoning AI Inc., a company founded by Cornell University artificial intelligence professors, today announced that the U.S. Food and Drug Administration has granted 510(k) clearance (K262134) for NeuroDR, its AI-enabled software for visualizing the arteries of the head and neck from CT angiography (CTA) scans. NeuroDR was developed in collaboration with 3DR Labs, the largest provider of 3D medical image post-processing in the United States,
MIAMI, Oct. 21, 2026 /PRNewswire/ — Resolve Therapeutics, LLC, a clinical-stage biotechnology company developing nuclease-Fc fusion proteins designed to degrade pathogenic extracellular nucleic acids, today announced two e-posters featuring preclinical data on its RNase-Fc fusion protein…
NEW YORK, Oct. 15, 2026 (GLOBE NEWSWIRE) — Precision Neuroscience Corporation (Precision), a brain–computer interface (BCI) company, today announced that Konstantinos Alataris, Ph.D., founder and former chief executive officer of Nevro, has joined as president, and Katherine Neuenfeldt, who led the U.S. launch and market access strategy for Nevro’s Senza spinal cord stimulation system, has joined as senior vice president, commercial strategies. Following Precision’s $250 million Series D financing, the two executives will advance the company’s BCI toward commercialization, drawing on their experience developing, launching, and securing reimbursement for implantable medical devices. “Precision has established a leading position in BCI technology, and our recent financing gives us the resources to take the next step,” said Michael Mager, co-founder and CEO of Precision. “Bringing a new Class III medical device to market takes more than technical skill and capital. We have to be able to build products that physicians can rely on and that insurers will pay for. Konstantinos and Katherine have done exactly that with implantable devices in the nervous system. Their experience will be critical as we move from demonstrating what our technology can do to making it available to patients.” Alataris has served on Precision’s board of directors since May 2025 and will continue in that role alongside his responsibilities as president. Alataris founded Nevro in 2006 and led the development and commercial launch of its high-frequency spinal cord stimulation technology for chronic pain. Nevro received European CE marking for its spinal cord stimulation system in 2010, went public on the New York Stock Exchange in 2014, and received FDA approval for the system in 2015, achieving a multi-billion dollar market capitalization. Beyond Nevro, Alataris has held executive and board roles across medical device, biotechnology, and pharmaceutical companies, including serving as president and CEO of Zosano Pharma, co-founding Nēsos, and chairing the scientific advisory board of Iota Biosciences until its acquisition by Astellas Pharma. He currently serves on the boards of Oryzon Genomics SA (BME: ORY), a clinical-stage biopharmaceutical company developing epigenetic therapies for cancer and central nervous system (CNS) disorders, and Delsona Therapeutics, a Columbia University spinout developing focused ultrasound therapeutics. He is also a partner and co-chairman at Forepont Capital, a New York-based private equity firm. Previously, he was a vice president at healthcare investment firm Bay City Capital. “Precision has demonstrated that it is possible to achieve high-performance neural control without penetrating the brain — something many believed couldn’t be done. That is a testament to the vision and dedication of co-founders Michael Mager and Ben Rapoport and the entire team,” Alataris said. “The next chapter is turning today’s breakthroughs into everyday medicine: reliable, repeatable, exceptional performance that neurosurgeons and patients can depend on, case after case. That is the work I wanted to help lead. Moving from the board into an operating role was a natural progression, an opportunity to roll up my sleeves and help bring the promise of Precision’s technology to patients.” Neuenfeldt leads Precision’s commercial strategy and market access efforts. She joined Nevro when the company had roughly 60 employees and led marketing for its successful 2015 U.S. launch of HF10 therapy. Later, as vice president of market access, she built and led a 40-person commercial team spanning national accounts, pricing and contracting, analytics, patient access, and reimbursement. Her team drove insurance coverage, adoption, and market differentiation for Nevro’s products globally. She previously spent six years at Medtronic Cardiovascular, where she led the U.S. launch of its flagship Endurant AAA stent graft, and most recently served as senior vice president of commercial strategies at Presidio Medical. “Joining Precision allows me to bring my experience launching disruptive medical devices backed by rigorous clinical evidence to a mission that is deeply personal to me,” Neuenfeldt said. “A device can be safe and effective, and a physician can want to use it, but if payers don’t cover it, patients won’t have access. For BCI technologies to reach people living with ALS, spinal cord injury, and brainstem stroke, we need to lay the groundwork for insurance coverage now, including generating clinical evidence that demonstrates meaningful benefits for patients.” The appointments follow Precision’s $250 million Series D financing, which brought its total capital raised to $430 million. Since its founding in 2021, Precision has built the largest clinical footprint in BCI, with more than 100 patient procedures across 18 medical institutions. The company has demonstrated high-resolution neural recording across 4,096 electrodes and real-time decoding of intended movement, received FDA clearance for its Layer 7™ cortical surface array, and published peer-reviewed research, including in Nature Biomedical Engineering. It has also established a commercial partnership with Medtronic and built a wholly owned MEMS manufacturing facility in Texas. About Precision NeurosciencePrecision Neuroscience is developing breakthrough treatments and technology for millions of people worldwide. The company is building the only brain–computer interface designed to be minimally invasive, safely removable, and high-bandwidth. To learn more about how Precision is connecting human and artificial intelligence, visit www.precisionneuro.io. Media Contactmedia@precisionneuro.io
HOUSTON–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) has accepted XCath’s Iris Surgical Robotic System into its Total Product Life Cycle Advisory Program (TAP) Pilot, the company announced today. The system is intended for remote robotic-assisted mechanical thrombectomy in patients with acute ischemic stroke. XCath is a medical device company advancing endovascular surgical robotics, and the FDA’s decision comes after it granted Breakthrough Device Designation to the Iris Syste
DALLAS–(BUSINESS WIRE)–NeuWire Medical today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for STROKE-REWIRE, a pivotal study evaluating the ReWire Vagus Nerve Stimulation System in patients with chronic ischemic stroke and upper-limb dysfunction. The prospective, multicenter, randomized, sham-controlled study will enroll up to 135 participants across up to 12 U.S. clinical sites. Study initiation is expected in t
IRVINE, Calif., Oct. 01, 2026 (GLOBE NEWSWIRE) — Balt announced today it has enrolled the first patients in North America in the premarket approval (PMA) clinical trial, PIONEER (PIvotal Study Of the Silk Vista Baby Flow Diverters iN the TrEatmEnt of Unruptured Intracranial AneuRysms). Pioneer is the first prospective trial exclusively assessing the role of flow diversion in the treatment of aneurysms in distal small arteries in the brain. This landmark trial is actively enrolling at hospitals in both the U.S. and Canada and is the U.S. approval study for the Silk Vista Baby flow diverter. Co-Primary Investigator, Vitor Mendes-Pereira, M.D., MSc (St. Michael’s Hospital, Toronto, Canada) stated, “The Silk Vista Baby has been a paradigm shift in the care of neurovascular patients. It provides physicians with a significant improvement on access to distal aneurysms with a low profile microcatheter over the treatment options we have available and enables us to provide better care for more patients.” The Silk Vista Baby device was the first flow diverter in the world that delivers through a small 0.017-inch diameter microcatheter. Obtaining European Union regulatory approval in 2018, the device has been used to treat thousands of aneurysm patients around the world and studied extensively in several clinical studies. Patients with distal brain aneurysms often have those aneurysms arise off very small blood vessels and the endovascular treatment options often require access devices that are too big, or the anatomy is not suitable for open surgical solutions. “The PIONEER study is an important advance for the care of aneurysm patients in the U.S.,” said co-Primary Investigator, Ricardo Hanel, M.D., PhD (Baptist Medical Center, Jacksonville, FL), “This study will add tremendously to our knowledge of how to care for patients with distal aneurysms and potentially brings another life-saving tool to the patients of the United States. One that has already changed care for much of the rest of the world.” Balt CEO Pascal Girin commented, “PIONEER marks the second PMA trial for Balt, following the groundbreaking STEM study which resulted in the PMA approval of the SquidTM Liquid Embolic for chronic subdural hematoma patients. We are currently working on multiple additional PMA studies and are committed to continue bringing Balt’s innovative solutions to novel indications for physicians and patients around the world.” About Balt: Since it was established in 1977, Balt has worked with interventional physicians to develop devices to treat complex life-threatening neurovascular diseases such as ischemic strokes, aneurysms and other hemorrhagic conditions including arteriovenous malformations, dural arteriovenous fistulas and chronic subdural hematomas. A pioneer in the neurovascular field, Balt designs, manufactures and distributes the broadest portfolio of products in the neurovascular space and is now focused on expanding its geographic presence in the U.S. Visit Balt at https://www.baltgroup.com/ ContactGreg ChodaczekGilmartin Groupgreg@gilmartinir.com
Proposed acquisition would add NeoCast™, an investigational technology designed for controlled delivery and predictable distal penetration, to Terumo Neuro’s neurovascular portfolio.
NeoCast
The next-generation in liquid embolics
Aliso Viejo, CA, Sept. 30, 2026 (GLOBE NEWSWIRE) — Terumo Neuro Signs Agreement to Acquire Arsenal Medical – Advancing Next-Generation Liquid Embolic Innovation for Treating Chronic Subdural Hematoma (cSDH) Proposed acquisition would add NeoCast™, an investigational technology designed for controlled delivery and predictable distal penetration, to Terumo Neuro’s neurovascular portfolio. Aliso Viejo, Calif. – September 29, 2026 – Terumo Neuro today announced that it has signed an agreement to acquire Arsenal Medical Inc., a privately held, clinical-stage biomaterials company developing NeoCast™, an investigational next-generation liquid embolic technology for the treatment of chronic subdural hematoma (cSDH). Upon completion, the proposed acquisition would expand Terumo Neuro’s liquid embolic portfolio, advance its strategy to bring differentiated neurovascular technologies to physicians and patients, and support its continued focus on innovations to preserve and restore brain health. “NeoCast represents a compelling opportunity to advance what could be a game-changing innovation in the treatment of chronic subdural hematoma,” said Carsten Schroeder, CEO, Terumo Neuro. “As MMA embolization emerges as an important new treatment option, this purpose-developed, next-generation liquid embolic technology has the potential to make a meaningful impact for physicians and patients, while supporting our mission to preserve and restore brain health. We are impressed by the progress Arsenal Medical has made and look forward to combining our global neurovascular expertise with its differentiated technology platform following the close of the transaction.” cSDH is a significant and growing neurological condition, particularly among aging populations. The condition may cause cognitive decline and disability, has been described as a potential cause of reversible dementia, and can be associated with substantial mortality within one year. While surgical drainage remains a common treatment approach, recurrence after surgery continues to be a clinical challenge. Middle meningeal artery embolization has emerged as a promising adjunctive or alternative approach by targeting the vascular pathology believed to contribute to hematoma persistence and recurrence.1,2,3 Arsenal Medical has developed NeoCast, a next-generation, solvent-free, non-adhesive biomaterial intended for embolization of the middle meningeal artery (MMA). It is engineered for controlled delivery and predictable distal penetration, without solvents or adhesives associated with many embolic devices. Arsenal Medical has advanced NeoCast through first-in-human clinical experience in cSDH and recently received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for RADIANT, a pivotal randomized, multicenter study evaluating NeoCast adjunctively with surgery for symptomatic subacute and chronic subdural hematoma.4 The first patients have been enrolled in RADIANT. Final results from the EMBO-02 first-in-human study showed that NeoCast met its primary feasibility and safety endpoints, with 96% of subjects achieving at least 50% hematoma volume reduction and 75% achieving complete hematoma resolution at final follow-up. Notably, 79% of 24 patients were treated with embolization alone, and 10 subjects were treated without general anesthesia.4 The study also reported functional outcome improvements, with 79% of patients demonstrating better functional status based on mRS and quality-of-life measures compared with baseline through 180 days. These findings are preliminary and provide supporting clinical context as NeoCast advances into RADIANT, a prospective, randomized, multicenter pivotal study comparing NeoCast to Onyx LES for the treatment of symptomatic subacute and chronic subdural hematoma adjunctively with surgery.5,6 “Arsenal Medical was founded on the idea that advanced materials can transform the way challenging medical conditions are treated,” said Upma Sharma, PhD, President and CEO, Arsenal Medical. “NeoCast is a powerful example of that vision. It was designed to provide physicians with controlled delivery and consistent distal penetration without the use of solvents or adhesives. Terumo Neuro’s leadership in neurovascular innovation makes it the ideal organization to help realize the full potential of NeoCast through its next stage of development following the close of the transaction.” NeoCast is an investigational device and is not approved for commercial sale in the United States. The proposed transaction is subject to customary closing conditions. Financial terms of the agreement were not disclosed. For more information, contact:Rebecca Janzon, Terumo Neuro, Global Director Corporate CommunicationsEmail: Rebecca.janzon@microvention.com About Terumo NeuroTerumo Neuro is on a mission to preserve and restore brain health by advancing innovation that changes what’s possible in neurovascular care. Working shoulder to shoulder with physicians, customers, and Associates, we turn deep clinical insight into proven, refined solutions that elevate practice and improve patient outcomes — the kind of game-changing impact that redefines neuro-endovascular treatment. Founded in 1997 as MicroVention and acquired by Terumo Corporation in 2006, Terumo Neuro offers a comprehensive portfolio for the treatment of cerebral aneurysms, ischemic stroke, carotid artery disease, and neurovascular malformations. Headquartered in Aliso Viejo, California, our products are sold in more than 70 countries.For more information, please visit www.terumoneuro.com. About Terumo CorporationTerumo (TSE: 4543) is a global medical innovation company. Guided by an unwavering commitment to patients, and driven by the passion of our associates, we strive to fulfill our Group Mission of “Contributing to Society through Healthcare.” Founded in Tokyo in 1921, we provide a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions. About Arsenal MedicalArsenal Medical is a privately-held, venture-backed, clinical-stage company developing innovative biomaterials to address challenging and underserved medical problems. Its lead product targets neurovascular conditions. The company was founded by academic luminaries Robert Langer and George Whitesides, together with entrepreneur investor Carmichael Roberts, who shared a vision for how materials can transform medical devices. Learn more at www.arsenalmedical.com. References Levitt MR, Hirsch JA, Chen M. Middle meningeal artery embolization for chronic subdural hematoma: an effective treatment with a bright future. J Neurointerv Surg. 2024 Mar 14Shankar JJS, Alcock S, Kashani N, et al.; EMMA-Can investigators. Management of Chronic Subdural Hematoma With Adjunctive Embolization of Middle Meningeal Artery: The EMMA-Can Randomized Clinical Trial. JAMA. Published online April 30, 2026Mascitelli Justin R, et al.; Current state of the field and recommendations for middle meningeal artery embolization in chronic subdural hematoma: A Report of the SNIS Standards and Guidelines Committee, Endorsed by ANZSNR and ESMINT. Journal of NeuroInterventional Surgery, April 2026Next-generation liquid embolic leads to “substantial” cSDH resolution and functional outcome gains. NeuroNews, July 24, 2026Arsenal Medical. Treatment with NeoCast, a Next-Generation Liquid Embolic, Results in Substantial Chronic Subdural Hematoma Resolution and Functional Outcome Gains in Final EMBO-02 First-in-Human Results. Press announcement issued July 22, 2026U.S. Food and Drug Administration. PMA Supplement Approval Letter: Onyx Liquid Embolic System (LES), P030004/S035. December 8, 2025 Contact Info Rebecca Janzonrebecca.janzon@microvention.com+1 949-685-4391
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Terumo Neuro Acquires Arsenal Medical
NeoCast
