Rhythm

HeartSciences Announces FDA 510(k) Submission for MyoVista® wavECG™ Device

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.

HeartBeam Receives FDA Clearance for First-Ever, Cable-Free Synthesized 12-Lead ECG for At-Home Arrhythmia Assessment

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 […]

Study Leverages Vivalink’s Biometrics Data Platform to Uncover Connection Between Seizures and Cardiac Function

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, […]

Catheter Precision Announces Launch of LockeT in Switzerland

Fort Mill, SC, Dec. 01, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market today announced the successful launch of its LockeT suture retention device in Switzerland. The first clinical cases were performed at Spitalzentrum Biel, led by PD Dr. Rainer Zbinden, with excellent procedural outcomes and positive feedback from both the clinical and nursing teams. This milestone follows the company’s recent strategic distribution agreement with FuMedica AG, a premier Swiss medical device distributor with a strong presence in cardiovascular and interventional medicine. The partnership enables the introduction of LockeT to hospitals and clinics across Switzerland, further expanding Catheter Precision’s European footprint. Fatih Ayoglu, Sales Manager EMEA & APAC at Catheter Precision, said, “We’ve recently partnered with FuMedica to distribute LockeT in Switzerland, and it’s already exciting to see the first cases roll out so quickly. LockeT is intuitive and easy to use—it reduces groin management costs and supports same-day discharge. With over 10,000 LockeTs shipped globally, we’re growing fast and working hard with our partners, one patient at a time.” About LockeTCatheter Precision’s LockeT is a suture retention device intended to assist in wound closure after percutaneous venous punctures. LockeT is a Class 1 device registered with the FDA and has received CE Mark approval. About Catheter PrecisionCatheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products. Cautionary Note Regarding Forward-Looking StatementsStatements in this press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to substantial risk and uncertainties. Forward-looking statements can be identified by words such as “believe,” “anticipate,” “may,” “might,” “can,” “could,” “continue,” “depends,” “expect,” “expand,” “forecast,” “intend,” “predict,” “plan,” “rely,” “should,” “will,” “may,” “seek,” or the negative of these terms and other similar expressions, although not all forward-looking statements contain these words.  These forward-looking statements include, but are not limited to, statements regarding product evaluations at the hospital, and that the purchase order indicates that the hospital and its staff see the value and benefits that LockeT can bring and expectations regarding LockeT evaluations in the coming weeks. The Company’s expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks and changes in circumstances, including but not limited to risks and uncertainties included under the caption “Risk Factors” in the Company’s Form 10-K filed with the SEC and available at www.sec.gov. The forward-looking statements included in this communication are made only as of the date hereof. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law. # # # CONTACT: CONTACTS:

Investor Relations
973-691-2000
IR@catheterprecision.com

Medtronic Aurora EV-ICD™ system demonstrates exceptional results at six months in the Enlighten real-world post-market study while the OmniaSecure™ defibrillation lead sustains performance at three years in the LEADR Pivotal Trial

APHRS.25: Medtronic showcases breadth of defibrillation portfolio with outcomes from extravascular and transvenous defibrillation studies for the treatment of dangerous heart rhythm episodes Cardiac Rhythm Management Researchers presented results from two late-breaking presentations at the Asia Pacific Heart Rhythm Society (APHRS) Scientific Session 2025 held in Yokohama, Japan. The six-month […]