FDA Approves InspireMD’s CGuard Prime Transcarotid Stent System for TCAR

November 12, 2026—InspireMD, Inc. announced that the FDA has approved the company’s premarket approval (PMA) supplement for the CGuard Prime transcarotid stent system for use in transcarotid artery revascularization (TCAR) procedures.

Insera’s Clear Aspiration System Cleared by FDA

November 12, 2026—Insera Therapeutics, Inc. recently announced FDA 510(k) clearance for its Clear aspiration system, which is intended for the removal of fresh, soft emboli and thrombi in the peripheral arterial and venous systems.

AVF Cohort Data Presented From WRAP Global Registry of Merit’s Wrapsody CIE

November 12, 2026—Merit Medical Systems, Inc. announced results from the arteriovenous fistula (AVF) cohort of the WRAP Global registry, which is evaluating the company’s Wrapsody cell-impermeable endoprosthesis (CIE) for the treatment of stenosis or occlusion within the dialysis outflow circuit of an AVF or an arteriovenous graft.

FDA Approves Contego’s Neuroguard IEP Direct System for TCAR-IEP

November 11, 2026—Contego Medical Inc. announced FDA premarket approval (PMA) of the Neuroguard IEP Direct system and 510(k) clearance of the Neuroguard IEP embolic protection system.

Medtronic’s Aristotle Mini Guidewire Cleared by FDA

November 10, 2026—Medtronic announced the launch of the Aristotle Mini guidewire, which received FDA 510(k) clearance in August 2026.

Evident Vascular’s Guidance System and Imaging Catheters Receive FDA Clearance

November 10, 2026—Evident Vascular, Inc. announced FDA 510(k) clearance of the Evident Vascular guidance system and Evident peripheral imaging catheters.

Meta-Analysis Examines Mortality With Mechanical Thrombectomy Versus Anticoagulation in Intermediate-Risk PE

November 4, 2026—The Society for Cardiovascular Angiography and Interventions (SCAI) announced findings from a systematic review and meta-analysis showing that mechanical thrombectomy was associated with lower short- and long-term mortality compared with anticoagulation alone in patients with intermediate-risk pulmonary embolism (PE).

CereVasc’s eShunt System Receives IDE Approval for Study in Early Symptomatic Alzheimer Disease

November 4, 2026—CereVasc, Inc. announced that the FDA approved an investigational device exemption application to evaluate the company’s eShunt system in patients with early symptomatic Alzheimer disease (AD).