The Latest Cardiac and Vascular News
Abbott’s Volt™ PFA System, the latest generation of cardiac ablation technology, is designed for people battling heart rhythm disorders such as atrial fibrillation (AFib) Pulsed field ablation – or PFA – is a minimally invasive procedure that uses high-energy electrical pulses in targeted…
CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL®, an Asahi Kasei company that manufactures medical devices and related software solutions, announced the U.S. launch of the next generation LifeVest® wearable cardioverter defibrillator (WCD). This marks the fifth FDA-approved LifeVest WCD, which works seamlessly with the recently launched next generation LifeVest WCD garment, the most comfortable LifeVest […]
HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel nPulse™ technology using its proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company’s Investigational Device Exemption (IDE), allowing Pulse Biosciences to […]
ATLANTA, Dec. 18, 2025 /PRNewswire/ — Huxley Medical, Inc. announced the SANSA® home sleep apnea test has received regulatory clearance from the United States Food and Drug Administration (FDA) to be used as a diagnostic ECG monitor, making SANSA the first home sleep apnea test capable…
Company secures first purchase order and multi-year commitment at Ireland’s largest electrophysiology center Company secures first purchase order and multi-year commitment at Ireland’s largest electrophysiology center
MIT-alumni-founded Thermedical advances novel deep-tissue ablation technology to address critical unmet needs in severe ventricular tachycardia WESTON, Mass.–(BUSINESS WIRE)–Thermedical®, a developer of advanced thermal-ablation technologies, today announced that the first patient has been treated in a pivotal clinical study evaluating its Saline Enhanced Radiofrequency (SERF) Ablation System with the Durablate® […]
Southlake, TX, Dec. 15, 2025 (GLOBE NEWSWIRE) — HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company advancing the use of ECG/EKGs through the integration of artificial intelligence (“AI”), today announced it has submitted its MyoVista® wavECG™ device to the U.S. Food and Drug Administration (“FDA”) for 510(k) premarket clearance.
December 10, 2025 7:00am ESTDownload as PDF FDA Clearance Granted After Successful Appeal, Overturning Prior Not Substantially Equivalent (NSE) Outcome HeartBeam’s Credit-Card Sized Device Delivers Clinical-Grade Insights Directly to Patients Anytime, Anywhere Pivotal Milestone Unlocks Multiple Key Initiatives in Company’s Growth Strategy SANTA CLARA, Calif.–(BUSINESS WIRE)– HeartBeam, Inc. (NASDAQ: BEAT), a […]
Version 1.1 Designed to Provide Best Usability of any ECG System Version 1.1 Designed to Provide Best Usability of any ECG System
Ochsner Health study explores how continuous cardiac monitoring can help assess seizure-related health risks and guide treatment decisions for patients with epilepsy Campbell, Calif. – Dec. 4, 2025 – Vivalink, a leading provider of digital healthcare solutions, is supporting a hospital-based study at Ochsner Health in New Orleans, LA, […]
