article thumbnail

HeartFlow AI Plaque Analysis Achieves Major Milestone Towards Medicare Coverage

DAIC

milla1cf Tue, 06/04/2024 - 20:54 June 4, 2024 — HeartFlow, a leader in cardiovascular healthcare technology, is pleased to announce a key Medicare policy development, which should allow for future expanded patient access to their Plaque Analysis product.

Medicare 104
article thumbnail

HRS, ACC Release Joint Statement on Intracardiac Catheter Ablation Procedures

DAIC

claims data from the Centers for Medicare & Medicaid Services (CMS). The field of EP continues to evolve due to improved workflows, technological innovations, and procedural advancements, said Samuel O. We are very excited for this HRS/ACC statement on SDD for EP ablations. Jones, MD, MPH, FACC, FHRS, Co-Chair of the document.

article thumbnail

Elixir Medical Granted FDA Breakthrough Device Designation for DynamX Bioadaptor

DAIC

The designation recognizes the novelty of the technology and the potential to provide a more effective treatment option for patients with coronary artery disease. 3 “We very much appreciate FDA’s breakthrough designation recognition of the bioadaptor technology,” continued Sirhan. Food and Drug Administration (FDA). of the U.S.

article thumbnail

CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

DAIC

Centers for Medicare & Medicaid Services (CMS) have granted the company’s Paradise Ultrasound Renal Denervation system a Transitional Pass-through (TPT) payment. tim.hodson Fri, 11/08/2024 - 09:57 Nov. 1, 2024 — Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co. recently announced U.S.

CMS 40
article thumbnail

ONC Releases HTI-2 Proposed Rule to Improve Health IT Interoperability, Update Standards For EHRs, More

American College of Cardiology

The Office of the National Coordinator for Health Information Technology (ONC) released on July 10 the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule, building on the HTI-1 final rule released in 2023 and additional information blocking rules released (..)

CMS 43
article thumbnail

New Legislation Speeds Progress on Patient Access to New Technologies

Society of Thoracic Surgeons - Technology

After a medical device or intervention has been proven to be safe and effective and reasonable and necessary for coverage, CED requires innovators to monitor how their technology performs in the real world. This process leads to earlier and safer patient access to new technologies and a more direct pathway to coverage for innovators.

article thumbnail

American Heart Association Announces New 2024-2025 National Volunteer Leaders

DAIC

For her outstanding leadership in advancing technology and risk management, she received the American Heart Association’s 2023 Morgan Stark Memorial Award. Recent reports from the American Heart Association outline a chasm of inequity that continues to grow at a critical time as our population becomes more richly diverse,” Churchwell said.