Dec. 18, 2025 — Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE Mark for its Amplatzer Piccolo Delivery System, which is used with the company's Amplatzer Piccolo Occluder. The new delivery system is designed specifically to treat premature babies (some weighing as little as two pounds) with a hole in the heart known as a patent ductus arteriosus (PDA).

Dec. 18, 2025 – Ventric Health, a medtech company enabling early detection of heart failure (HF) in a primary care setting, has announced publication of outcomes from the FDA validation study demonstrating the high accuracy of the novel Vivio System in non-invasively detecting HF using left ventricular end-diastolic pressure (LVEDP), considered the definitive HF measure.

Dec. 11 2025 — Valvular heart disease, identified through cardiovascular imaging, is common in cancer patients. Interventions to treat valvular heart disease significantly improved survival.1 These findings were presented at EACVI 2025, the flagship congress of the European Association of Cardiovascular Imaging (EACVI), a branch of the European Society of Cardiology (ESC).

Dec. 10, 2025 — HeartBeam, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s 12-lead electrocardiogram (ECG) synthesis software for assessing arrhythmias. This clearance follows HeartBeam’s successful appeal of a prior Not Substantially Equivalent (NSE) determination.

Dec. 15, 2025 — HeartSciences Inc., a healthcare information technology company advancing the use of ECG/EKGs through the integration of artificial intelligence, has submitted its MyoVista wavECG device to the U.S. Food and Drug Administration (FDA) for 510(k) premarket clearance.

Dec. 15, 2025 — Royal Philips has entered into an agreement to acquire SpectraWAVE, Inc., an innovator in enhanced vascular imaging (EVI) of coronary arteries, angiography-based physiology assessments and the use of AI in medical imaging3. SpectraWAVE’s intravascular imaging and physiological assessment technologies provide solutions for treating patients with coronary artery disease, the most frequent type of heart disease, affecting 300+ million people worldwide4.

Dec. 11, 2025 — Heartflow, Inc., a provider of AI technology for coronary artery disease (CAD), recently announced two new analyses from FISH&CHIPS, a real-world, multicenter, retrospective study of more than 90,000 patients conducted by the National Health Service (NHS) in England, representing the largest fractional flow reserve (FFRCT) study ever conducted.

Dec. 8, 2025 — In November, The Lancet published an international expert consensus review, “Contemporary, non-invasive imaging diagnosis of chronic coronary artery disease”, that shows using CT coronary angiography (CTCA) when patients exhibit low to intermediate pre-test probabilities (PTP) for coronary disease can lead to more cardiac patients being accurately diagnosed, which helps save lives.  Currently, the testing is not readily available at many medical facilities, and guidelines generally recommend against routine testing for low PTP (<5%).

Dec. 10, 2025 — The Singapore-MIT Alliance for Research and Technology (SMART), Massachusetts Institute of Technology’s (MIT) research enterprise in Singapore, has launched a new collaborative research project – Wearable Imaging for Transforming Elderly Care (WITEC).

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.

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