Jan. 6, 2026  — UltraSight, a provider of AI-guided cardiac imaging workflows, has announced FDA clearance to expand its Echo Stewardship Platform to support compatibility with additional ultrasound system types, including handheld, laptop, and cart-based systems. This expanded authorization helps health systems scale AI-guided focused cardiac ultrasound (FoCUS) using compatible ultrasound equipment they already own, without hardware replacement.

Jan. 13, 2026 – Innovative Health, Inc. has received its 50th clearance from FDA to reprocess single-use medical devices used in electrophysiology and cardiology labs. This latest clearance is to reprocess the Agilis NxT Steerable Introducer, originally manufactured by Abbott, for two additional uses in the lab. Innovative Health is the only reprocessing company that is cleared to reprocess this market-leading introducer two times.

Jan. 13, 2026 — A streamlined, nurse-led response for hospitalized patients experiencing an acute stroke at a Texas academic medical center improved time from symptom discovery to imaging and treatment, which is associated with better outcomes.

Researchers Perform First Minimally Invasive Coronary Artery Bypass

In a world first, a team of researchers at the National Institutes of Health (NIH) and Emory School of Medicine, Atlanta, has successfully performed a coronary artery bypass — a normally open-heart surgery — without cutting the chest wall. The team employed a novel intervention to prevent the blockage of a vital coronary artery, which is a very rare but often lethal complication following a heart-valve replacement.

Jan. 8, 2026 — AccurKardia recently announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the commercial launch of its AccurECG Analysis System (v2.0) (K252361). AccurECG 2.0 builds on AccurKardia’s previously FDA-cleared AccurECG platform, representing the next-generation of the company’s enterprise-grade ECG interpretation system. The AccurECG platform has now secured two separate FDA 510(k) clearances.

Jan. 13, 2026 —  AliveCor has received U.S. Food and Drug Administration (FDA) clearance for the next generation of KAI 12L— the AI powering the Kardia 12L ECG System — to detect five additional cardiac determinations, bringing the total to 39 cleared determinations. This expansion further enhances the diagnostic breadth of the world’s first AI-powered, handheld 12-lead electrocardiogram (ECG) system with a unique single-cable design, providing healthcare providers with unprecedented clinical depth in a compact, portable form factor.

Jan. 13, 2026 — Kestra Medical Technologies, a wearable medical device and digital healthcare company, has announced a strategic collaboration with Biobeat Technologies, Ltd. to expand diagnostic insight for patients prescribed the Assure Wearable Cardioverter Defibrillator (WCD). The agreement is anchored by an exclusive license and co-development arrangement and includes a $5 million equity investment in Biobeat’s recently announced Series B financing.

Medtronic has announced the commercial launch of the OmniaSecure defibrillation lead in the U.S., with first cases being performed at hospitals across the country. 

The world’s smallest-defibrillation lead — approved for adults and the first for pediatric patients ages 12 and up — connects to an implantable defibrillator to treat potentially life-threatening heart rhythm issues like ventricular tachyarrhythmias, ventricular fibrillation (VT/VF) and bradyarrhythmias. 

Jan. 8, 2026 — Compremium AG recently announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its novel solution designed to directly measure central venous pressure (CVP) non-invasively. The device has also joined the FDA’s Total Product Life Cycle Advisory Program (TAP).

Jan. 12, 2026 — YorLabs, Inc., a medical technology company providing next-generation intracardiac imaging solutions for electrophysiology (EP) and interventional cardiology (IC), has successfully completed the first clinical procedure using its FDA 510(k)-cleared YorLabs Intracardiac Imaging System. The procedure marks the first real-world clinical use of YorLabs' Zero-CapEx imaging platform following U.S. Food and Drug Administration clearance.

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