FDA Clearance

Yokneam's Rapid Medical Announces FDA Clearance of DRIVEWIRE™ 35 and First Stroke Cases

Yokneam's Rapid Medical Announces FDA Clearance of DRIVEWIRE™ 35 and First Stroke Cases

First steerable 0.035-inch guidewire combines controlled tip deflection and distal support to accelerate catheter access; builds on nearly 5,000 DRIVEWIRE™ 24 cases. Jeremy Rempel, MD, of the University of Alberta Hospital in Edmonton, Canada, performed the first clinical cases worldwide, including successfully navigating catheters to treat an intracranial occlusion without crossing the clot.

MST Receives FDA Clearance for “Follow Me™” Image-Guided software for Minimally Invasive Robotic Surgery

MST Receives FDA Clearance for “Follow Me™” Image-Guided software for Minimally Invasive Robotic Surgery

“Securing FDA clearance for the Follow-Me™ software is a major milestone for MST, making AutoLap® the only market-approved image-based system with image-guided functions for various minimally invasive laparoscopic procedures,” said Motti Frimer, CEO of MST. “We are already commercializing AutoLap® with the Follow Me™ software in Europe, and we now look forward to expanding marketing and sales of the surgeon-focused system in the U.S. in 2016.”