Nov. 18, 2025 — RapidAI announced U.S. Food and Drug Administration (FDA) clearance of Aortic Management, part of the Rapid Aortic product, a comprehensive deep clinical AI solution designed to transform the acute assessment and longitudinal management of aortic disease.

Nov. 18, 2025 — Harrison.ai has launched its CE-marked CT Chest solution, a comprehensive AI tool that assists clinicians in detecting 167 radiological features, including those that may be suggestive of life-threatening conditions, tumors, and chronic diseases.

 Nov. 11, 2025 -— Integra LifeSciences Holdings Corp. has announced the FDA 510(k) clearance for use of its CUSA Clarity Ultrasonic Surgical Aspirator System for cardiac surgeries. The recent clearance for specific cardiac indications encompasses the debridement of unwanted tissue in cardiac surgeries, including valve replacement and repair.

Nov. 17, 2025 — GE HealthCare has announced that Cardiovascular Associates of America (CVAUSA) plans to broaden its adoption of GE HealthCare’s FDA-approved cardiac positron emission tomography (PET) radiotracer Flyrcado (flurpiridaz F 18) injection, across approximately 25 sites following a successful pilot at Cardiovascular Medicine in Davenport, Iowa. This planned rollout marks a significant milestone for advancing PET myocardial perfusion imaging (MPI) in community cardiology settings and reflects growing confidence in Flyrcado’s role in shaping the future of cardiac imaging.

Nov. 12, 2025 — The Association of Black Cardiologists (ABC) has released new findings from a national survey exposing a widespread gap in awareness regarding cholesterol and cardiovascular health. These insights reinforce the urgency of the organization’s “Every Heart Counts: ABC Cardiology Deserts Campaign” — a nationwide initiative addressing persistent disparities in access to heart health education and care in under-resourced regions across the country.

Nov. 13, 2025 — Esaote has announced a new strategic partnership with Schiller Americas. This collaboration strengthens both companies' presence in the cardiovascular imaging market and marks a major step forward in bringing Esaote's advanced ultrasound technology to more U.S. healthcare providers.

Nov. 12. 2025 — The American Heart Association’s Council on Clinical Cardiology has selected Roxana Mehran, MD, as the recipient of its 2025 Laennec Master Clinician Award. Mehran is Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai.

This award recognizes Dr. Mehran’s individual lifetime achievements in patient care and cardiology education. She was presented with this award during  at the American Heart Association’s Scientific Sessions in New Orleans.

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. 

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