Search Results

InspireMD Announces PIs for C-GUARDIANS II Trial Evaluating the SwitchGuard Neuroprotection System

February 12, 2024—InspireMD, Inc. named Patrick Geraghty, MD, and Patrick Muck, MD, as the lead Principal Investigators (PIs) for the company’s upcoming C-GUARDIANS II clinical trial for the SwitchGuard neuroprotection system (NPS).  According to the company, the C-GUARDIANS II study will aim to advance clearance of SwitchGuard NPS and associated tools, which are designed to allow the treating physician to reverse cerebral blood flow during a transcarotid artery revascularization procedure, preventing embolic debris generated during the procedure from traveling to the brain by passing the blood through the filter enclosed within the SwitchGuard before returning it to the patient to minimize blood loss.

Rampart Guardian Radiation Protection System Evaluated in EVAR Procedure

December 3, 2025— Rampart IC, a developer of radiation shielding for interventional suites, announced new data on the reduction in radiation exposure achieved using the Rampart Guardian system, a lead-free, total-body, total-team protection solution.

Complete 24-Month Data Presented From the Pivotal VISION Study of Avinger's Lumivascular Technology

May 31, 2017—Avinger, Inc. announced positive 2-year clinical data from the pivotal VISION study of the company’s Lumivascular technology for use in the treatment of peripheral artery disease (PAD).

InspireMD Earns IDE Approval for CGUARDIANS II Pivotal Study

October 7, 2024—InspireMD, Inc., developer of the CGuard embolic prevention stent system for the prevention of stroke, announced that the FDA has approved the company’s application for an investigational device exemption (IDE) to initiate the CGUARDIANS II pivotal study of the company’s CGuard Prime 80-cm carotid stent system during TCAR (transcarotid artery revascularization) procedures.

InspireMD Commences CGUARDIANS II Pivotal Study of CGuard Prime Carotid Stent System in TCAR

December 9, 2024—InspireMD, Inc. announced that the first patient has been enrolled in the company’s CGUARDIANS II clinical trial evaluating its CGuard Prime carotid stent system in patients undergoing carotid artery stenting via the transcarotid artery revascularization (TCAR) approach.

IDE Approved for Pivotal Study of InspireMD’s SwitchGuard Neuro Protection System

May 14, 2026—InspireMD, Inc., developer of the CGuard Prime carotid stent system for the prevention of stroke, announced that the FDA has approved the company’s investigational device exemption (IDE) application to initiate the CGUARDIANS III pivotal study.

Pivotal Study Begins for InspireMD’s SwitchGuard NPS in TCAR Procedures

June 8, 2026—InspireMD, Inc. announced that the first patient has been enrolled in the CGUARDIANS III pivotal study of its SwitchGuard neuroprotection system (NPS).

Viz.ai’s AAA Algorithm Receives FDA 510(k) Clearance

March 21, 2023—Viz.ai announced it has received FDA clearance for its algorithm intended to detect suspected abdominal aortic aneurysms (AAAs).