Bendit Announces FDA Clearance for the Bendit17™ Steerable Microcatheter

TEL AVIV, Israel, Dec. 10, 2025 /PRNewswire/ -- Bendit Technologies is proud to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Bendit17™ Microcatheter, the smallest steerable microcatheter on the market. This milestone marks a significant step forward in advancing precision and accessibility in neurovascular and peripheral endovascular interventions.

The FDA clearance enables Bendit to bring its innovative technology to physicians and patients across the United States. The company is in the final stages of production and preparing to initiate its first U.S. commercial clinical procedures beginning in January 2026. In parallel, Bendit is actively pursuing additional regulatory clearances in other global territories.

Oz Cabiri, CEO of Bendit Technologies, commented:
"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. 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. Its unique capabilities are designed to support clinicians across a broad range of intricate vascular procedures.

About Bendit Technologies
Bendit Technologies is a medical device company developing 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.

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Contact Details
Oz Cabiri
CEO, Bendit Technologies
Email: [email protected]

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SOURCE Bendit Technologies