Oct. 24, 2025 —YorLabs, Inc., a medical technology company developing next-generation intracardiac imaging solutions for electrophysiology (EP) and interventional cardiology (IC) procedures, recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's YorLabs Intracardiac Imaging System — a zero-capex ultrasound platform designed to simplify workflow, reduce cost, and enhance procedural efficiency inside the cath lab.

Oct. 27, 2025 — The American Heart Association (Association) has launched its latest professional certification program to help bridge the gap between traditional practice and remote patient monitoring and care, while promoting privacy and compatibility with existing health care systems.

Oct. 27, 2025 – Penumbra, Inc. has announced the results of the STORM-PE randomized controlled trial (RCT), which found that the use of mechanical thrombectomy, specifically computer assisted vacuum thrombectomy (CAVT), with anticoagulation achieved superior reduction in right heart strain compared to anticoagulation therapy alone in patients with acute intermediate-high risk pulmonary embolism (PE). The data was presented at a late-breaking session during the 37th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco.

Oct. 21, 2025 — SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), recently announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its wire-free, drug-free, single angiogram derived physiology product, X1-FFR. X1-FFR provides physicians physiology results from a single angiogram acquired via a direct real-time angiography feed, eliminating the need for network-based DICOM file management and transfer delays.

Oct. 22, 2025 — Heartflow, Inc. has introduced Heartflow PCI Navigator, the newest addition to the Heartflow One platform. PCI Navigator is an integrated, AI-driven percutaneous coronary interventions (PCI) planning tool that gives interventional cardiologists a patient-specific 3D model — detailing anatomy, plaque composition, and lesion-specific physiology — all aligned to optimize potential stent placement. For the first time, interventional cardiologists can plan PCIs with relevant information brought together in one intuitive view before their patients are in the cath lab.

Oct. 22, 2025 — Qure has announced its latest (510) K clearance from the US Food and Drug Administration (FDA). 

Oct. 22, 2025 — Nyra Medical, a leading innovator in structural heart therapies, has announced the initiation of its first-in-human clinical study evaluating its novel Cardiac Leaflet Enhancer (CARLEN) System in patients with functional (secondary) mitral regurgitation (FMR).

The study, focused on clinical safety and technical performance, has successfully enrolled more than 10 patients, many with at least 30-day follow-up to date. The early clinical experience marks a significant milestone in the company's mission to transform the treatment of mitral valve disease.

Oct. 22, 2025 — Basking Biosciences, a clinical-stage biopharmaceutical company developing the first reversible thrombolytic therapy for acute ischemic stroke (AIS), recently announced the first patients dosed in Part B of its Phase 2 RAISE trial of BB-031. BB-031 is an investigational RNA aptamer targeting von Willebrand Factor (vWF), a key mediator of clot formation and stabilization.

Oct. 21, 2025 — Early and accurate detection of heart rhythm problems can mean the difference between life-saving intervention and a missed opportunity, which is why new advances in cardiac diagnostics carry such weight. HeartBeam has reported promising results from its pivotal VALID-ECG study (https://ibn.fm/BDiIa), demonstrating that its synthesized 12-lead ECG technology delivers a strong correlation with the clinical gold standard of traditional 12-lead ECGs for non-life-threatening arrhythmias. 

Oct. 21, 2025 – AskBio Inc., a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, has announced the publication in peer-reviewed journal Nature Medicine of 12-month data from its Phase 1 trial of AB-1002 investigational gene therapy in participants with congestive heart failure (CHF).1

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