Sept. 3, 2025 — Laza Medical, Inc., a developer of AI-powered robotic ultrasound image guidance technology, has announced the successful completion of its first software-only human cases at a top-tier U.S. medical institution. This milestone marks the first time Laza's real-time, AI-based heart model has been evaluated alongside real clinical procedures. The software operated concurrently during live cases to enable retrospective analysis and performance assessment.

New Clues in Finding Silent Arrhythmias

Patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) are at elevated risk for cardiovascular disease.1 Yet arrhythmias like atrial fibrillation (AFib), which are one of the biggest predictors of heart disease, remain silent until patients suffer a major adverse cardiovascular event (MACE) such as stroke or heart failure.2 Despite this reality, routine screening for arrhythmias is uncommon in most diabetes care pathways.3

Sept. 3, 2025 — Kardium Inc. recently announced it has received pre-market approval (PMA) for the Globe Pulsed Field System and 510(k) clearance for both the Globe Introducer sheath and the Globe Pulsed Field System mapping software from the U.S. Food and Drug Administration (FDA).

Sept. 2, 2025 — Imperative Care, Inc. has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Symphony Thrombectomy System to treat pulmonary embolism (PE).

This clearance expands the use of Symphony — previously for the treatment of venous thrombosis — to now include PE, providing a comprehensive solution to effectively and efficiently treat the full spectrum of venous thromboembolism (VTE) patient needs.

Aug. 29, 2025 — GE HealthCare has launched Vivid Pioneer, its most advanced, ultra-premium and adaptive cardiovascular ultrasound system yet, completely redesigned to support clinicians with imaging in 2D, 4D and color flow, streamlined workflow, and enhanced diagnostic confidence. The ultrasound system recently received CE Mark and U.S. FDA 510(k) clearance.

The Vivid Pioneer is on display during the European Society of Cardiology 2025, Aug. 29–Sept., 1 in Madrid, Spain. 

Aug. 28, 2025 — A new global systematic literature review and meta-analysis has shown that herpes zoster vaccination, used to prevent shingles, is associated with a statistically significant lower risk of heart attack and stroke.   

The study is the first global systematic literature review and meta-analysis to comprehensively assess the evidence regarding an association between herpes zoster vaccination and cardiovascular events.   

Aug. 27, 2025 – HeartFocus, the AI-enabled cardiac imaging software developed by data-driven medtech company DESKi, announced its U.S. commercial launch. HeartFocus will initially be available on Butterfly Network’s handheld ultrasound devices, the FDA-cleared software enables any healthcare professional to conduct diagnostic-quality heart ultrasounds after just hours of training. Health systems, primary care clinics, and clinical education institutions can now access the application. 

Aug. 28, 2025 — Medtronic plc has announced it received U.S. Food and Drug Administration (FDA) approval for the expanded Redo-TAVR indication of the Evolut transcatheter aortic valve replacement (TAVR) system. This approval allows for the implantation of a new Evolut transcatheter aortic valve (TAV) inside any failed previously implanted TAV and follows CE Mark for Evolut PRO+, FX and FX+ systems. 

The Redo-TAVR procedure is indicated for patients experiencing failure of any TAV, including but not limited to severe aortic stenosis, who are at high-risk for open-heart surgery. 

HIMSS Global Health Conference & Exhibition

Aug. 26, 2025 — Octane, an innovative organization building the SoCal of Tomorrow by connecting people, resources and capital to fuel technology growth in Southern California, has announced that the Octane Cardiovascular Tech Forum 2025 (CTF) will take place Sept. 11–12, 2025, in Newport Beach, California.

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