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.

Jan. 12, 202 — Abbott and AtaCor Medical have announced a collaboration to advance a next-generation investigational extravascular implantable cardioverter defibrillator (EV-ICD) system designed to deliver defibrillation therapy to people with life-threatening heart rhythms.

AtaCor is a cardiac rhythm management (CRM) company developing extravascular defibrillation technologies designed to reduce risks associated with traditional ICDs. Through the collaboration, AtaCor's investigational parasternal EV-ICD lead (Atala) will be paired with Abbott's investigational ICD system.

Jan. 12, 2026 — HeartLung Corp. has announced U.S. Food and Drug Administration (FDA) clearance of AI-CVD, its AI-powered quantitative imaging platform, under 510(k) K252029.

Jan. 6, 2026 — Millions of Americans living with heart failure are not receiving medications that have been proven for decades to significantly reduce the risk of death, according to a new nationwide analysis released by Motive Medical Intelligence, a healthcare data and analytics company.

Robotics in EP and Cath Labs

Robotic Magnetic Navigation (RMN) emerged two decades ago as an alternative approach to performing complex ablation procedures inside cardiac catheterization and electrophysiology (EP) labs. Several meta-analyses link RMN to lower complication rates and less fluoroscopy time compared to manual navigation approaches.1,2 However, implementing RMN platforms has traditionally required significant architectural planning and other hurdles, limiting their adoption and making them out of reach for many community hospitals.

Jan. 9, 2026 — Effective January 1, 2026, Elucid's Plaque-IQ coronary plaque analysis has received a new Category I Current Procedural Terminology (CPT) designation, alongside increasingly widespread coverage and reimbursement from both public and private payors. Together, these developments underscore the clinical value of coronary plaque analysis and establish favorable conditions for broader adoption of the technology.

Jan. 7, 2026 — UltraSight, a provider of AI-guided cardiac imaging workflows, has partnered with Jefferson Health, one of the largest academic health systems in the United States, in a clinical study to advance rapid incorporation of diagnostic-quality FoCUS echocardiogram workflows. The pilot is funded in part by the Israel Innovation Authority (IIA) through the Jefferson–Israel 2025 Health Tech Pilot Program, which provides Israeli companies with real-world clinical environments to evaluate new technologies, accelerate validation, and support successful entry into the U.S.

Jan. 6, 2026 — Cleerly, a leader in AI-based cardiovascular imaging, has announced that Aetna will begin covering Cleerly LABS plaque analysis effective immediately. Aetna, which covers more than 20 million lives, joins UnitedHealthcare, Cigna, Humana, BCBS Kansas City, Excellus BCBS, and EviCore in providing coverage for this advanced technology.

Dec. 10, 2025 — Medtronic plc has announced the first commercial use of the Liberant thrombectomy system (Liberant). Indicated for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems, Liberant expands the Medtronic portfolio of treatment options for peripheral arterial and venous diseases to include mechanical aspiration thrombectomy.

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