Radical Catheter Technologies, backed by NeuroTechnology Investors, received FDA 510(k) clearance for its 8F catheter, expanding its neurovascular product line. This follows the earlier clearance of the 7F catheter and coincides with the completion of a new state-of-the-art manufacturing facility. The expansion of catheter sizes and enhanced manufacturing capabilities positions the company for significant commercial growth.

This clearance is crucial for the neurovascular field as it provides clinicians with an additional, larger-diameter catheter option based on the company’s patented ribbon technology. The 8F catheter offers broader therapeutic possibilities, potentially improving outcomes in complex neurovascular procedures. The new facility enables Radical Catheter Technologies to meet anticipated demand as adoption of its technology increases.

The 8F catheter builds upon the success of the 7F version, offering similar benefits in flexibility, stability, and durability. The larger inner diameter expands treatment options for physicians. The new manufacturing facility is expected to support full-scale commercialization of the Radical Catheter platform.

This recent FDA clearance and the completion of the new manufacturing facility mark a significant step forward for Radical Catheter Technologies. The company is now poised to aggressively pursue broader market penetration and establish its catheter technology as a leading solution in the neurovascular space. This progress may lead to wider adoption of the technology, potentially impacting the standard of care in neurovascular interventions.

Source link: https://www.globenewswire.com/news-release/2025/01/15/3010107/0/en/Radical-Catheter-Technologies-8F-Neurovascular-Catheter-Receives-US-FDA-510-k-Clearance-Second-for-the-Best-in-Class-Ribbon-Technology-Platform.html

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.