Bendit Technologies Receives FDA Clearance for World's Smallest Steerable Microcatheter
核心洞察
Bendit Technologies (搜索) has received FDA 510(k) clearance for the Bendit17™ Microcatheter, described as the smallest steerable microcatheter on the market.
The device enables controlled navigation through complex anatomies with or without a guidewire, representing a significant technological advancement in endovascular procedures.
Commercial clinical procedures in the United States are scheduled to begin in January 2026, with the company pursuing additional regulatory clearances globally.
Bendit Technologies (搜索) announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the Bendit17™ Microcatheter, marking a significant milestone in endovascular intervention technology. The device is positioned as the smallest steerable microcatheter currently available on the market, designed to advance precision and accessibility in neurovascular and peripheral endovascular procedures.
The FDA clearance enables the Tel Aviv-based medical device company to introduce its innovative technology to physicians and patients across the United States. Bendit Technologies (搜索) is currently in the final stages of production and preparing to initiate its first U.S. commercial clinical procedures beginning in January 2026.
Revolutionary Navigation Technology
The Bendit17 Microcatheter (搜索) introduces enhanced steerability and precision capabilities that enable controlled navigation through complex anatomies while maintaining stability, control, and ease of use. A key technological advancement of the device is its capability to navigate with or without a guidewire, which represents what the company describes as a significant technological leap forward in the field.
"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," said Oz Cabiri, CEO of Bendit Technologies (搜索). "The device's capability to navigate with or without a guidewire represents a significant technological leap forward."
Advanced 3D Steering Capabilities
The company's proprietary technology enables real-time 3D steering and improved navigability through complex anatomies. These unique capabilities are specifically designed to support clinicians across a broad range of intricate vascular procedures, with the goal of empowering healthcare providers and improving patient outcomes in minimally invasive endovascular interventions.
The microcatheter's design focuses on enhancing accuracy, accessibility, and efficiency in procedures that require precise navigation through challenging vascular pathways. This technological approach addresses the need for greater control and precision in complex endovascular care.
Global Expansion Plans
In parallel with its U.S. market preparation, Bendit Technologies (搜索) is actively pursuing additional regulatory clearances in other global territories. This strategic approach reflects the company's mission to expand access to advanced endovascular technology worldwide.
"Our mission is to push the boundaries of what is possible in endovascular care, and the Bendit17 embodies that vision," Cabiri added. "We look forward to bringing this technology available to physicians in the U.S. and supporting improved care for patients worldwide."
The company specializes in developing advanced steerable microcatheters designed to enhance the precision and effectiveness of minimally invasive endovascular procedures, with a focus on improving both clinical outcomes and procedural efficiency.