Demonstrating commitment to continuous portfolio innovation, Centerline Biomedical receives FDA 510(k) clearance for new IOPS® Guidewire Handle and launches its latest software advancements
CLEVELAND, Dec. 4, 2024 /PRNewswire/ — Centerline Biomedical, Inc. (“Centerline”), an innovative leader in cardiovascular navigation and visualization systems, announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance for its new IOPS Guidewire Handle. This second-generation device is the most recent addition to the company’s novel, patented IOPS (Intra-Operative Positioning System) technology portfolio. The IOPS Guidewire Handle is used with the sensorized IOPS Guidewire and new Viewpoint™ Catheter to support 3D navigation of a patient’s vasculature. When combined with the proprietary algorithms of the IOPS software, clinicians are able to clearly visualize these devices in real-time and with minimized dependence on fluoroscopy during procedures.
