Supira’s SUPPORT II Pivotal Trial of pVAD System Approved by FDA

April 9, 2026—Supira Medical, Inc. announced FDA approval to initiate the SUPPORT II pivotal trial of the Supira percutaneous ventricular assist device (pVAD) system.

ALERT Study of Integrated EHR Platform Addresses Health Disparities in Structural Heart Disease Treatment

April 6, 2026—Medtronic announced data from the ALERT trial, which is designed to address health disparities and undertreatment in structural heart care using an integrated electronic health record (EHR) platform.

Haemonetics Receives FDA Approval to Expand Vascade MVP XL Label

April 1, 2026—Haemonetics announced that it has received FDA approval for expanded labeling of its Vascade MVP XL venous vascular closure system to include procedures using with 10- to 14-F inner diameter (ID) and up to 17-F outer diameter (OD) sheaths, according to a company press release.

CLOSURE-AF Finds LAA Closure Fails to Meet Noninferiority Versus Medical Therapy

March 18, 2026—Catheter-based left atrial appendage (LAA) closure did not achieve noninferiority compared with physician-directed best medical care in patients with atrial fibrillation (AF) at high risk for both stroke and bleeding, according to results from the randomized CLOSURE-AF trial published by Landmesser et al in The New England Journal of Medicine.1 CLOSURE-AF is a prospective, multicenter, randomized controlled trial conducted across 42 sites in Germany.

Emboline Secures Funding for Commercialization of Emboliner Embolic Protection System

March 13, 2026—Emboline, Inc., announced it has closed $20 million in growth capital that will support preparations for the commercial introduction of the company’s Emboliner embolic protection system while continuing development of additional technologies designed to reduce embolic risk during structural heart interventions.

FDA Clears Cara Medical’s CTA-Based Platform for Cardiac Conduction System Visualization

February 27, 2026—Cara Medical Ltd. announced that the FDA has granted 510(k) clearance for the Cara system, a CTA-based platform that provides noninvasive, patient-specific three-dimensional (3D) visualization of the cardiac conduction system.

Gore Completes Acquisition of Conformal Medical

February 19, 2026—Gore & Associates announced it has completed its acquisition of Conformal Medical, developer of the investigational CLAAS AcuFORM System, a next-generation left atrial appendage occlusion (LAAO) technology.

VERITAS Study Evaluates Abbott Amulet 360 LAA Occluder in Nonvalvular AFib

February 13, 2026—Abbott recently announced positive early results from the VERITAS study evaluating its investigational Amulet 360 left atrial appendage (LAA) occluder in patients with nonvalvular atrial fibrillation (AFib).

Salus Scientific AeroShield Radiation Protection Used in First Clinical Case

February 10, 2026—Salus Scientific and Tallahassee Memorial HealthCare (TMH) announced the first clinical use of AeroShield, a table-mounted, inflatable enhanced radiation protection device (ERPD), marking what the organizations described as the first deployment of the technology in a live catheterization laboratory setting.

Joint Commission Partners With STS and ACC in New Cardiac Care Certification

January 30, 2026—Joint Commission announced it has partnered with the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) to leverage clinical performance data for a new cardiac care certification.

Burl’s Foqus Ultrasound System for Detecting PFO Used in First-in-Human Cases

January 29, 2026—Burl Concepts, a developer of a test for evaluating cerebral blood flow and detecting emboli, announced the first human uses of the company’s Foqus ultrasound system for detection of brain emboli.

Haemonetics Acquires Vivasure Medical

January 12, 2026—Haemonetics Corporation announced the acquisition of Vivasure Medical Limited, an Ireland-based developer of technology for percutaneous vessel closure.

Gore to Acquire Conformal Medical

January 5, 2026—Gore & Associates announced that it has entered into a definitive agreement to acquire Conformal Medical, Inc., which is developing the investigational CLAAS AcuForm system, a left atrial appendage occlusion (LAAO) device.

New ACC/AHA Guideline Addresses Management of Congenital Heart Disease in Adults

December 24, 2025—The American College of Cardiology (ACC) and the American Heart Association (AHA) have issued a new guideline for managing congenital heart disease in adults.

Abbott’s Amplatzer Piccolo Delivery System Approved to Treat PDA in Premature Babies

December 18, 2025—Abbott announced it has received FDA clearance and CE Mark approval for its Amplatzer Piccolo delivery system, which is used with the company’s Amplatzer Piccolo occluder.

Imaging Study Evaluates Valvular Heart Disease and Interventions in Cancer Patients 

December 11, 2025—The European Society of Cardiology announced findings from a study showing that valvular heart disease as identified through cardiovascular imaging is common in cancer patients and that interventions significantly improved survival in these patients.

Recross PFO Sealing System Early Feasibility Study Commences 

December 8, 2025—Recross Cardio Inc., a structural heart company developing next-generation membrane sealing technology, announced the first clinical implantation of the Recross patent foramen ovale (PFO) sealing system in the PROTEA-PFO early feasibility study (EFS).

Cardiawave’s Valvosoft Approved in Europe for Treatment for Severe Symptomatic Aortic Stenosis

December 4, 2025—Cardiawave announced it has received CE Mark approval for Valvosoft noninvasive ultrasound therapy (NIUT) device for the treatment of severe symptomatic aortic stenosis (sSAS).

Cordis-X’s FASTEN Trial of Ladera Large-Bore Closure System Advances Enrollment

October 24, 2025—Cordis-X announced that it has enrolled the first 25 patients in the FASTEN trial in pursuit of CE Mark approval for Ladera Medical’s investigational large-bore closure system.

Ancora Heart’s AccuCinch System Shows Sustained Reverse Remodeling at 2 Years 

October 24, 2025—Ancora Heart, Inc. announced the publication of 2-year outcomes from early clinical studies of its AccuCinch transcatheter left ventricular restoration system.