Radical™ Catheter Technologies Announces U.S. FDA 510(k) Clearance for its 6F Neurovascular Catheter -- Broadening Access Across a Wide Range of Applications
Radical Catheter Technologies Continues to Expand its Best-in-Class Patented Platform and Scale its Specialized Neurovascular Commercialization Team
LOS GATOS, Calif., April 13, 2026 (GLOBE NEWSWIRE) -- Radical™ Catheter Technologies, a NeuroTechnology Investors (NTI) portfolio company, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to its 6F neurovascular access catheter. This latest milestone marks another important step as Radical Catheter Technologies accelerates the evolution of its catheter platform. The 6F joins the company’s first two FDA-cleared catheters and broadens therapeutic options, particularly for middle-meningeal artery (MMA) embolization, and further expands availability in radial access procedures.
“The FDA clearance of the 6F Radical catheter is a meaningful advancement for our patients,” said Johanna Fifi, MD, neurovascular surgeon and Professor of Neurosurgery, Neurology, and Radiology at The Mount Sinai Hospital, New York, NY. “The 6F’s lower profile delivers best-in-class performance across both radial and femoral access. Built on the foundation Radical Catheter Technologies has already established, the 6F becomes an immediate top choice, particularly in challenging cases.”
“We have spent years developing a truly innovative, best-in-class catheter platform that directly addresses performance gaps physicians have long identified. With our novel technology, we are exceeding these expectations and positioning the Radical platform to serve as the foundation for continued innovation in neuroendovascular procedures,” said Brian Martin, CEO and co-founder of Radical Catheter Technologies.
The Radical catheter is built on patented ribbon technology designed to deliver simultaneous flexibility, push, and stability, along with the durability physicians need when navigating complex anatomy. With a thinner wall construction that provides a greater inner diameter relative to outer diameter and a smooth, continuous liner to enable the delivery of other therapeutic devices, the Radical platform provides significant mechanical advantages to support procedural efficiency and performance.
Beyond catheters, Radical Catheter Technologies is actively broadening its commercialization model by integrating its neurovascular access and delivery capabilities with synergistic technologies across the NTI portfolio. A prime example is Serenity Medical's River™ stent — recently granted FDA Humanitarian Device Exemption (HDE) approval for adult patients with severe, refractory idiopathic intracranial hypertension (IIH) — which exemplifies the caliber of innovation Radical Catheter Technologies is positioned to bring to market.
“The FDA 510(k) clearance of our latest 6F access catheter further validates the breadth of our platform across a wide range of neurovascular applications,” said Alex Thomson, Vice President of Commercial at Radical Catheter Technologies. “This commercialization model unites some of the most compelling technologies in the neurovascular space, while providing the infrastructure to advance and support the best-in-class solutions we represent.”
Radical Catheter Technologies is planning to exhibit its patented technology platform at the Society of Neurointerventional Science’s (SNIS) 23rd Annual Meeting, July 20-24, 2026, in Seattle, Washington, together with fellow innovative NTI portfolio companies, including Synchron, Serenity Medical, and Borvo Medical. Members of Radical Catheter Technologies’ commercialization team will be on-site to engage attendees and discuss how the company is expanding access to its platform and supporting the rollout of innovative neurovascular technologies.
About Radical™ Catheter Technologies and the Neurovascular Commercialization Team
Radical Catheter Technologies is a pioneering medical device company advancing its patented catheter platform designed to support next-generation endovascular access and delivery. Radical Catheter Technologies fields a specialized commercial team with deep expertise to support bringing breakthrough medical technologies to market. Radical catheters have the potential to provide best-in-class performance to every neurovascular procedure currently performed. This provides the commercial team with a unique opportunity to include other promising technologies aligned with partners, such as those from NTI, in a portfolio of innovative neurovascular and neurosurgical solutions.
About NeuroTechnology Investors (NTI)
NeuroTechnology Investors (NTI) is a leading investment group dedicated to advancing breakthrough neurological technologies in the medical device sector, with a diverse portfolio that includes Synchron, Radical Catheter Technologies, Borvo Medical, and Serenity Medical. Established in 2016 and headquartered in Mountain View, California, NTI investors bring extensive clinical expertise to accelerate portfolio company development and improve patient access to transformative clinical solutions.
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TellMed Strategies
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908-884-7024
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