Bendit Technologies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Bendit17 Microcatheter, reportedly the smallest steerable microcatheter on the market. The authorization could help advance precision and accessibility in neurovascular and peripheral endovascular interventions, according to the company.

The FDA clearance enables Bendit to bring its technology to U.S. physicians and patients. The company is in the final stages of production and preparing to initiate its first U.S. commercial clinical procedures this month. In parallel, Bendit is actively pursuing additional regulatory clearances in other global territories.

“FDA clearance of the Bendit17 is a major milestone for our team and a meaningful advancement for clinicians seeking greater control and navigational precision in complex vascular procedures,” Bendit Technologies CEO Oz Cabiri commented. “The device’s capability to navigate with or without a guidewire represents a significant technological leap forward. Our mission is to push the boundaries of what is possible in endovascular care, and the Bendit17 embodies that vision. We look forward to bringing this technology available to physicians in the U.S. and supporting improved care for patients worldwide.”

The Bendit17 Microcatheter introduces a new level of steerability and precision, enabling controlled navigation through complex anatomies while maintaining stability, control, and ease of use, Bendit Technologies bigwigs claim. Its unique capabilities are designed to support clinicians across a broad range of intricate vascular procedures.

Bendit Technologies develops advanced steerable microcatheters designed to enhance accuracy, accessibility, and efficiency in minimally invasive endovascular procedures. The company’s proprietary technology enables real-time 3D steering and improved navigability through complex anatomies, helping empower clinicians and improve patient outcomes.