Coronary/Structural Heart

HeartFlow Announces New Reimbursement Code and Increased Payment for FFRCT

MOUNTAIN VIEW, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) — HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) precision coronary solutions, announced FFRCT was transitioned to a Category I Current Procedural Terminology (CPT®) code beginning January 1, 2024. The new code, designated by The American Medical Association (AMA), supports FFRCT […]

New Survey Reveals 86 Percent of Benefits Leaders Recognize Need for Heart Health Strategy in 2024

MENLO PARK, Calif.–(BUSINESS WIRE)–Hello Heart, the digital leader in preventive heart health, today released its inaugural Why Heart Health Matters Report, which examines the toll that cardiovascular disease (CVD) takes on employers, health plans, and the people they serve. The report surveyed 300 benefits leaders at large employers and health plans […]

Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™

REHOVOT, Israel–(BUSINESS WIRE)–Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it received Breakthrough Device Designation from the US Food and Drug Administration for ShortCut™ – the world’s first dedicated leaflet modification device facilitating valve-in-valve Transcatheter Aortic Valve Replacement […]

Sensydia Completes Fifth Study for Heart-Sound AI

LOS ANGELES–(BUSINESS WIRE)–Non-invasive cardiac assessment company Sensydia announced today that it has completed its 50-subject development study at the University of Minnesota (UMN). This study was conducted at UMN to collect data for its innovative AI-powered, non-invasive Cardiac Performance System (CPS™) that uses heart sound analysis to enable earlier detection and more effective therapy […]

AM-Pharma Initiates Phase 2 Trial of Ilofotase Alfa for Cardiac Surgery-Associated Renal Damage

UTRECHT, The Netherlands, January 16, 2024–(BUSINESS WIRE)–AM-Pharma B.V. today announced that the first patients have been treated in a Phase 2 clinical study evaluating the company’s proprietary recombinant alkaline phosphatase, ilofotase alfa, as a preventive treatment for cardiac surgery-associated renal damage (CSA-RD). With over 2 million open heart surgeries1 performed worldwide every year, CSA-RD […]

Ultromics Announces Partnership to Expedite Development of Echo AI Algorithm for Early Detection of Cardiac Amyloidosis

OXFORD, England, Jan. 10, 2024 /PRNewswire/ — Ultromics, a patient outcomes-focused AI-driven health technology company with roots at the University of Oxford, UK, has entered into an agreement with Pfizer to support the validation and FDA clearance of its AI-based technology for the…

Cleerly® Launches Cleerly® ISCHEMIA™ Solution for Heart Disease Analysis

DENVER–(BUSINESS WIRE)–Cleerly, the company working to create a new standard of care for the diagnosis of heart disease, today announced the launch of Cleerly ISCHEMIA, which recently received U.S. Food and Drug Administration (FDA) 510(k) medical device clearance. Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, intended […]

Paragonix SherpaPak Recognized for Maximizing Access to the Donor Pool in New Clinical Study

WALTHAM, Mass.–(BUSINESS WIRE)–Paragonix Technologies, a pioneer in organ transplant solutions, is proud to announce the publication of new groundbreaking data reflecting the clinical impact of its flagship advanced preservation device, the Paragonix SherpaPak Cardiac Transport System (CTS), to protect and monitor donor hearts from extended criteria donors. In organ transplantation, an extended criteria donor is defined as having perceived risk factors linked to poor subsequent outcomes, for

SS Innovations Achieves Significant Milestones in 2023

Company’s award winning SSi Mantra surgical robotic system has completed over 550 surgeries and is clinically validated to perform more than 40 different types of surgical procedures Company Builds Strong Foundation for Future Growth FORT LAUDERDALE, Fla., Jan. 08, 2024 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or […]

Applied Therapeutics Announces Topline Results from the ARISE-HF Phase 3 Study of AT-001 in Diabetic Cardiomyopathy

AT-001 (caficrestat) demonstrated a strong trend in stabilizing cardiac functional capacity, while the placebo group declined over 15 months AT-001 treatment resulted in a statistically significant difference in cardiac functional capacity in a prespecified subgroup of patients not receiving concomitant treatment with an SGLT2 or GLP-1 (p=0.040) and prevented clinically […]