The Next Chapter of IVL

Since receiving FDA approval in 2016, intravascular lithotripsy (IVL) systems have grown in popularity among interventionalists for treating calcified plaque inside coronary and peripheral arteries. Now, IVL has reached a major milestone, treating 1 million patients worldwide, according to data released at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 meeting in San Francisco in October.

Nov. 12, 2025 — Siemens has announced plans to deconsolidate its remaining stake in Siemens Healthineers (currently circa 67 percent). The company plans to transfer 30 percent of Siemens Healthineers shares to Siemens AG shareholders by way of a direct spin-off as preferable option. Thus, Siemens shareholders will benefit directly and receive shares in Siemens Healthineers. At the same time, the deconsolidation will provide potential to unlock long-term value for Siemens shareholders as a more focused technology company with a highly synergistic Siemens portfolio. 

Nov. 11, 2025 — FastWave Medical has successfully completed enrollment in its 30-patient coronary feasibility study and received its ninth U.S. patent from the United States Patent and Trademark Office (USPTO) — two major milestones in the advancement of the company's Sola laser intravascular lithotripsy (L-IVL) system.

Nov. 12, 2025 —  On Nov. 11, Huntsman Cancer Institute at the University of Utah (the U) opened its first specialized angiography-CT suite to enhance treatment options offered in interventional radiology, a field of medicine that uses imaging to conduct minimally invasive procedures. The only one of its kind in the Mountain West, this new technology aims to improve patient outcomes and reduce travel burdens for patients.

Cardiac PET/CT — A New Standard for Cardiac Imaging

Cardiac PET/CT represents a major advancement in cardiovascular diagnostics, offering significant clinical and operational advantages over traditional methods such as SPECT imaging. Its precision, safety and efficiency are transforming how clinicians diagnose, treat and manage heart disease — delivering faster results, greater accuracy and improved patient outcomes.

1. Superior Diagnostic Accuracy

Nov. 12, 2025 — AISAP, a provider of AI Point-of-Care Diagnostics, has announced a field initiative in Ghana, deploying the company's FDA-cleared AI-powered cardiac diagnosis platform. The program will support the African country's first nationwide training program for cardiac sonographers and improve early detection of heart failure and valvular disease.

Nov. 10, 2025 —Genomics, a science-led techbio company, has today announced new research that suggests polygenic risk scores (PRS) can significantly improve the predictive performance of the cardiovascular disease (CVD) risk prediction tool, PREVENT. The findings were presented at the American Heart Association Conference 2025.1

Nov. 10, 2025 — Kestra Medical Technologies, a wearable medical device and digital healthcare company, has announced primary results from the ASSURE WCD Clinical Evaluation Post-Approval Study (ACE-PAS), presented as a late-breaking science session at the American Heart Association (AHA) Scientific Sessions 2025 in New Orleans. ACE-PAS, the largest prospective real-world study of wearable defibrillators to date, confirmed the strong safety and effectiveness of the ASSURE WCD in clinical practice.

Nov. 10, 2025 — Stereotaxis has received U.S. Food and Drug Administration 510(k) clearance for its latest generation robotic system, GenesisX.

Nov. 8, 2025 — Sanjay Rajagopalan, MD, MBA, Chief of Cardiovascular Medicine at University Hospitals Harrington Heart & Vascular Institute and Director of the Case Cardiovascular Research Institute at Case Western Reserve University School of Medicine, has earned the 2025 American Heart Association Distinguished Scientist Award. This honor, the highest bestowed by the Association, recognizes individuals whose work has significantly advanced the understanding of cardiovascular disease and stroke.

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