Rhythm

AtriCure Announces that the First Patient has been Treated with the Revolutionary AtriClip® FLEX-Mini™ Device

MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, today announced that the first patient was treated with the AtriClip® FLEX-Mini™ device, which recently received 510(k) clearance. The AtriClip FLEX-Mini sets a new standard […]

PaceMate® Acquires Medtronic Paceart Optima™ System, Bringing Complementary Capabilities to Cardiac Data Management

August 27, 2024 08:00 AM Eastern Daylight Time SARASOTA, Fla.–(BUSINESS WIRE)–PaceMate®, a pioneer in cardiac data management and remote monitoring, announced today the acquisition of the Paceart Optima™ system, an on-premises cardiac workflow solution from Medtronic (NYSE: MDT.) This strategic move significantly expands PaceMate’s reach globally, adding nearly 1,000 clinic locations worldwide. This […]

Biosense Webster Completes Enrollment of Omny-IRE Clinical Trial Investigating the OMNYPULSE™ Large-tip Focal Pulsed Field Ablation Catheter

Study evaluates the safety and effectiveness of the OMNYPULSE™ Platform in Europe and Canada Irvine, CA – August 26, 2024 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i announced the enrollment completion of the Omny-IRE clinical trial. Omny-IRE is a prospective, multi-center, […]

Adagio Medical Provides Business Updates

August 19, 2024 04:01 PM Eastern Daylight Time LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc. (Nasdaq: ADGM; the “Company”), a leading innovator in catheter ablation technologies for treatment of cardiac arrhythmias, today provided a business update. “For years there has been underinvestment in and pent-up demand for innovation in ablation […]

Leading Cardiac Diagnostics Innovator Zywie Announces Industry Partnership With MedAxiom

ATLANTA–(BUSINESS WIRE)–Zywie, a cardiovascular diagnostics pioneer specializing in remote cardiac monitoring through wearable biosensor devices and cloud-based data analytic solutions, announced today a partnership with MedAxiom, the cardiovascular community’s premier source for organizational performance solutions. “We are proud to welcome Zywie to the MedAxiom community” Post this “We are proud to welcome Zywie to the […]

Atraverse Medical Announces First Clinical Use of HOTWIRE™ Radiofrequency (RF) Guidewire System at St. Bernards Medical Center

SAN DIEGO, July 30, 2024 /PRNewswire/ — The HOTWIRE™ RF guidewire device by Atraverse Medical, a San Diego-based medical device company, has been used for the first time in clinical practice by world-renowned cardiac electrophysiologist, Dr. Devi Nair, at St. Bernards Medical Center. The…

Innovation Value Institute Analysis Demonstrates HeartSciences’ MyoVista® wavECG™ Potential to Improve Cardiovascular Pathway Efficiency

Southlake, TX, July 26, 2024 (GLOBE NEWSWIRE) — Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced an analysis published by the Innovation Value Institute (IVI) titled “Introduction of AI assisted Digital Health Technology to Improve Cardiovascular Pathway Efficiency” focused on the MyoVista® wavECG™’s potential to radically improve the cardiovascular pathway efficiency.

HeartSciences Selected to Demonstrate MyoVista® wavECG™ at the United Nations General Assembly Digital Health Symposium as a Technology to Radically Transform Healthcare

Southlake, TX, July 25, 2024 (GLOBE NEWSWIRE) — Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that the MyoVista® wavECGTM has been selected by the Innovation Value Institute as a technology which can drive the radical transformation of healthcare and has been invited to demonstrate and discuss the MyoVista wavECG at the 4th Digital Health Symposium at the United Nations General Assembly to be held in New York, USA in September 2024.

Volta Medical Enters into Joint Development Agreement with GE HealthCare to Enhance Arrhythmia Procedures with AI-Driven Electrophysiology Technologies

Collaboration aims to address challenges in capturing and analyzing cardiac signals to help physicians enhance patient outcomes for atrial fibrillation procedures Collaboration aims to address challenges in capturing and analyzing cardiac signals to help physicians enhance patient outcomes for atrial fibrillation procedures

AliveCor’s Kardia 12L ECG System Receives Category III CPT Codes

New Codes Establish Path to Reimbursement for First-of-its-Kind Cardiac Technology
MOUNTAIN VIEW, Calif., July 17, 2024 /PRNewswire/ — AliveCor, the global leader in AI-powered cardiology, today announced that the American Medical Association (AMA) has granted new Category III Current Procedural Terminology (CPT) codes that are applicable to the company’s Kardia™ 12L ECG System, which received FDA clearance in June 2024. In accordance with the AMA semi-annual early release schedule, the new codes will be effective January 1st, 2025 and published in the 2025 CPT Code book.
CPT codes are widely used by government payers, including Medicare and Medicaid, and commercial insurance companies to identify healthcare services and procedures for reimbursement. Category III CPT codes allow data collection for new or emerging healthcare approaches and establish a foundation that facilitates reimbursement pathways for healthcare providers.
The following Category III codes for Kardia 12L were accepted by the CPT Editorial Panel meeting for the 2025 CPT production cycle:

0903T Electrocardiogram, Algorithmically generated 12-lead ECG from a reduced-lead ECG; with interpretation and report
0904T ECG ALG 12 Algorithmically generated 12-lead ECG from a reduced-lead ECG; tracing only
0905T Electrocardiogram, Algorithmically generated 12-lead ECG from a reduced-lead ECG; interpretation and report only

“Cardiovascular disease continues to be the leading cause of death in the US, and this recognition from the AMA brings new momentum towards improving access to life-saving cardiac care, including our latest technology,” said Sanjay Voleti, CBO of AliveCor. “Our AI-powered, portable Kardia 12L is AliveCor’s first device developed exclusively for use by healthcare providers, paving the way to bring this clinically-validated ECG technology to patients anytime and anywhere.”
About Kardia 12L ECG and KAI 12L AI Technology
Kardia 12L ECG System combines the power of KAI 12L’s AI technology and the pocket-sized Kardia 12L, to enable faster, easier detection of life-threatening cardiac conditions. KAI 12L is the world’s first AI to detect 35 cardiac determinations, including heart attacks, using a reduced leadset.
Kardia 12L ECG System is battery-operated, weighs just 0.3 pounds – making it significantly smaller, more portable and easier to use than conventional 12-lead ECGs. Its streamlined leadset also makes it less invasive for patients, who do not need to fully disrobe during a reading. The device requires minimal self-guided training and is simpler and faster to use than standard 12-lead ECG machines. These features put 12-lead ECG data within reach of more healthcare providers than ever before in a variety of healthcare facilities and acute settings, including primary and urgent care offices, employer clinics, and other under-resourced or rural venues.
For healthcare providers interested in purchasing a Kardia 12L, please visit alivecor.com/products/kardia12L.
About AliveCor
AliveCor, Inc., the leading provider of FDA-cleared personal electrocardiogram (ECG) technology, is transforming cardiology with its medical-grade AI solutions. AliveCor is committed to providing innovative devices and services that empower patients and physicians with personalized and actionable heart data. With over 250 million ECGs recorded, the company’s Kardia devices are the most clinically validated personal ECGs in the world and can remotely detect six of the most common heart arrhythmias in just 30 seconds. The company’s latest offering, Kardia 12L ECG System, powered by KAI 12L to detect 35 cardiac conditions (14 arrhythmias and 21 morphologies), was designed exclusively for use by healthcare providers. AliveCor’s enterprise platform allows third-party providers to manage their patients’ and customers’ heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies, addressing gaps in care and improving the treatment experience for patients across a range of disease areas. AliveCor is a privately held company headquartered in Mountain View, Calif. For more information, visit alivecor.com and follow us on LinkedIn, X, Instagram and Facebook.
SOURCE AliveCor, Inc.