Oct. 2, 2025 — AorticLab recently announced the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) for the FLOWer System pivotal clinical investigation. The FLOWer System is an innovative full-body embolic protection device designed for use during transcatheter intracardiac procedures. Since obtainment of the CE mark under MDR in Q1 2024, FLOWer has been successfully utilized in very complex procedures, in several EU countries.

Sept. 26, 2025 — A new guideline from the American Society of Echocardiography (ASE) offers updated and expanded recommendations aimed at improving the quality, clarity and consistency of echocardiography reports across diverse clinical settings.

Oct. 1, 2025 – Intelerad has announced the next generation of InteleHeart, a reimagined, all-in-one cardiology platform that unifies viewing, reporting, analytics, and workflow orchestration in a single solution. By bringing fragmented systems together, InteleHeart gives cardiologists, clinical leaders and care teams a whole picture of patient cardiac health, enabling them to streamline operations and make faster, more confident decisions that improve patient outcomes. 

Medtronic Hybrid Ablation

Hypertension remains the leading modifiable driver of cardiovascular disease and premature death.1 Even with multiple drug classes available, nearly 70% of adults have uncontrolled blood pressure.2

Sept. 30, 2025 — Biograph and Caristo Diagnostics have announced a partnership for Biograph to become the first U.S. clinic to study a novel AI-based preventive cardiac marker in asymptomatic patients, by detecting coronary artery inflammation from cardiac CT scans.

Sept. 29, 2025 — Many studies have shown the inverse relationship between bone mineral density (BMD) — the gold standard measure for osteopenia/osteoporosis and coronary calcium (CAC) — a biomarker of heart attack and stroke risk. For example, mild (osteopenia) or more severe (osteoporosis) low BMD is associated with elevated CAC/cardiovascular disease (CVD) risk. A new NIH-funded long term longitudinal study stratifies this association — showing different levels of low BMD corresponding to different levels of elevated CAC.

Sept. 30, 2025 — Cleerly has announced that coverage policies from UnitedHealthcare and Cigna for Cleerly LABS advanced plaque analysis will go into effect Oct. 1, 2025. These landmark decisions mark a new era in cardiac care, bringing AI-guided quantitative coronary CT angiography (AI-QCT)/Coronary Plaque Analysis (AI-CPA) within reach of millions of Americans.

Starting Oct. 1, 2025, patients will have access through streamlined coverage criteria that mirrors Medicare's established local coverage determinations and EviCore’s recently updated guidelines.

Sept. 29, 2025 — Radiation therapy may offer a comparable and potentially safer alternative to repeat catheter ablation for patients with severe abnormal heart rhythms that can no longer be controlled with medication.

Sept. 29, 2025 — AngioSafe has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its flagship product, the Santreva-ATK Endovascular Revascularization Catheter, enabled by its proprietary Atheroplasty technology platform. Santreva-ATK also received CE marking in July 2025 and was successfully used in the first real-world patient procedures in Italy earlier this month.

Sept. 25, 2025 — Royal Philips has entered a national partnership in the United States with Optum Healthcare. The inclusion of Philips’ Mobile Cardiac Telemetry (MCOT) and Philips Extended Holter (ePatch) in Optum Healthcare's network is designed to enable earlier detection of cardiac conditions and timely clinical intervention.

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