Nov. 25, 2025 — Remington Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance and announced the commercial launch of the second-generation VascuChek Doppler. VascuChek is a handheld vascular Doppler device for clinical and surgical use. With the addition of a Bluetooth external speaker, VascuChek 2.0 gives clinicians and surgeons superior audio clarity and volume to more accurately assess patients’ blood flow during surgeries.

Nov. 30, 2025 – Ascend Cardiovascular, a provider of purpose-built enterprise imaging for cardiology, and Konica Minolta Healthcare Americas, Inc., a provider of medical diagnostic imaging and healthcare IT solutions, have announced a strategic partnership to deliver a unified and complete enterprise imaging solution for hospital cardiology departments and cardiology practices.

Dec. 3, 2025 — Atraverse Medical, a medical device company developing next-generation left-heart access technology, has received 510(k) clearance from the U.S. FDA for its fully integrated HOTWIRE Transseptal Access System. 

Dec. 3, 2025 — Recross Cardio Inc., a structural heart company developing next-generation membrane sealing technology, recently announced the first clinical implantation with its novel PFO Sealing system in the PROTEA-PFO Early Feasibility Study (EFS). The procedure was successfully performed by Dr. Carey Kimmelstiel and his interventional team at Tufts Medical Center in Boston, Massachusetts.

Dec. 2, 2025 — At RSNA 2025, Siemens Healthineers announced Syngo.CT Coronary Cockpit1, a new software solution within the Syngo.via2 platform designed to support the management of coronary artery disease (CAD) for both dual-source and photon-counting CT scanners. As the leading cause of death globally and a major contributor to disability,3 CAD continues to pose a significant global health challenge. This drives increasing demand for diagnostic and treatment planning tools that are both efficient and minimally invasive.

Dec. 2, 2025 — Brainomix, a provider of AI-powered imaging tools in stroke and lung fibrosis, has announced the publication of a prospective real-world study demonstrating that its AI imaging platform, Brainomix 360 Stroke, significantly increased rates of endovascular thrombectomy (EVT) treatment, a minimally invasive surgical procedure for patients with large vessel occlusion stroke, and reduced delays in patient triage and transfer.

CT-First Gains Momentum

More than 1 million patients undergo a cardiac catheterization each year,1 but those numbers could decline as more cardiologists look toward coronary computed tomographic angiography (CCTA) as the first test to diagnose coronary artery disease (CAD).
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CCTA

Dec. 1, 2025 — Cleerly, a provider of AI-based cardiovascular imaging, will showcase new product updates at RSNA 2025. At Booth #8039, Cleerly will demonstrate PowerScribe integration and newly added lesion-level reporting, discuss new clinical research findings, and provide guidance on the plaque analysis Category I CPT code effective Jan. 1, 2026.

Nov. 30, 2025 — KA Imaging Technology has announced that its Reveal 35C detector with SpectralDR technology will be featured in two scientific presentations at the Radiological Society of North America (RSNA) annual meeting in Chicago, Ill.

The abstracts, led by independent investigators, explore the potential role of dual-energy chest X-ray in cardiac imaging applications:

Dec.1, 2025 – MannKind Corp. has announced that the U.S. Food and Drug Administration (FDA) has accepted the sNDA seeking approval for FUROSCIX ReadyFlow Autoinjector (SCP-111), developed to deliver a subcutaneous furosemide injection in less than 10 seconds as an investigational alternative to the FDA-approved FUROSCIX (furosemide) On-body Infusor for treatment of edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD). The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.

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