Coronary/Structural Heart

Agitated Solutions Receives IND Clearance from FDA to Initiate Phase 3 Clinical Trial of a Novel Contrast Agent

Multi-center trial will assess safety and efficacy of ASI-02 contrast agent in cardiac bubble studies. ST. PAUL, Minn.–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) has cleared Agitated Solutions, Incorporated (ASI)’s Investigational New Drug (IND) application for its novel contrast agent, ASI-02, enabling the initiation of the company’s Phase 3 clinical trial. […]

FDA Grants SeaStar Medical Two New Breakthrough Device Designations for SCD Therapy to Treat Systemic Inflammatory Response in Adult and Pediatric Patients Undergoing Cardiac Surgery

DENVER, April 08, 2025 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that the U.S. Food and Drug Administration (FDA) has granted SeaStar Medical two new Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy. The two new Breakthrough Device Designations are indicated for the treatment of systemic inflammatory response in 1) adult patients undergoing cardiac surgery and 2) pediatric patients undergoing cardiac surgery towards prevention of post-operative adverse complications and outcomes. Approximately 15 percent of the estimated 300,000 adults that undergo cardiac surgery each year are considered high risk and, we believe, could benefit most from the SCD therapy to prevent post-surgical complications. Of the 40,000 pediatric patients that undergo congenital heart surgery each year, we believe that approximately one third might benefit from SCD therapy.

CardioVia Announces FDA Clearance for ViaOne, Opening a New Frontier in Minimally Invasive Heart-Surface Treatments

TEL AVIV, Israel, April 8, 2025 /PRNewswire/ — CardioVia, an innovative medical device company specializing in advanced cardiac care solutions, announced today that it has received U.S. Food and Drug Administration (FDA) clearance for its ViaOne system. This breakthrough device is…

AMA Approves CPT Codes for Caristo’s AI-Powered Heart Disease Risk Stratification and Prevention Technology

New CPT codes mark a major step toward making Caristo’s CaRi-Heart®—the first AI-powered tool to detect coronary inflammation from routine CT scans—available in everyday clinical care Rewriting the rules of cardiac risk assessment, Caristo moves beyond anatomy to reveal the biological…

Teladoc Health Introduces Next Generation Cardiometabolic Health Program

New resources aim to improve population health and prevent the progression of diabetes, hypertension and obesityPURCHASE, NY, April 08, 2025 (GLOBE NEWSWIRE) — Teladoc Health (NYSE: TDOC), the global leader in virtual care, today introduced its next generation Cardiometabolic Health Program to improve population health and prevent the progression of diabetes, hypertension and obesity. Building on the company’s industry-leading chronic condition management programs, the new offering is designed to support optimal cardiometabolic health for all populations. The program drives healthier behaviors by targeting fundamental measures of cardiometabolic health: diet, physical activity, sleep, stress management, weight, blood lipids, blood glucose, blood pressure and nicotine exposure. These behaviors and health factors also align with Life’s Essential 8, the American Heart Association’s key measures for improving and maintaining cardiovascular health. Studies show that only 12% of adults in the U.S. have optimal cardiometabolic health. Without intervention and support, the vast majority of the working population is at risk of progressing to serious and costly conditions. Teladoc Health’s Cardiometabolic Health Program addresses these challenges and provides the tools, coaching and support necessary to drive improved outcomes. New features for members and customers include: A premium subscription to BetterSleep, the award-winning app that promotes sleep quality and well-being.Access to a registered dietitian for 1:1 support, medical nutrition therapy and personalized nutrition planning.Proactive outreach from expert health coaches for those at highest risk.Convenient at-home testing for key cardiometabolic measures, including A1c and blood lipids.Dynamic health insights that leverage patient-reported data and inputs from Teladoc Health’s connected devices— blood glucose meters, blood pressure monitors and connected scales—as well as CGM devices to help empower better outcomes.Seamless integration with Teladoc Health’s 24/7 Care and primary care providers, as well as connected care partners who can care for related conditions like joint pain and digestive health needs. “Nutrition, activity, sleep and stress management all have an outsized impact on population health. Our program comprehensively addresses these foundational pillars of cardiometabolic health because we know that’s what it takes to deliver meaningful outcomes—both for those managing multiple conditions and those looking to avoid progression of disease,” said Kelly Bliss, Teladoc Health President of U.S. Group Health. “Conditions and their risk factors are often interconnected, and with the right tools and behavior changes, they can be prevented.” The new program builds on Teladoc Health’s industry-leading individual condition management programs, which deliver proven results. For example, a recent analysis of more than 210,000 members enrolled in Teladoc Health’s diabetes management program showed 58% of participants achieved remission-level A1c. In the hypertension program, 88% of participants improved or maintained their blood pressure after one year. Data also shows that Teladoc Health’s digital mental health support accelerates positive results across the company’s hypertension, diabetes and weight management programs. Teladoc Health also places 100% of program fees at risk, as a sign of confidence for customers that the programs will help their populations achieve new levels of cardiometabolic health. The new program is part of Teladoc Health’s integrated care segment strategy to deepen its impact on healthcare outcomes and follows recent enhancements in its chronic care management offerings. In the last few months alone, the company has expanded its at-home testing and preventative care capabilities, enhanced its weight management programs, and unveiled new collaborations, partnerships and platform capabilities to help more people discover and enroll in eligible programs. To learn more about Teladoc Health’s cardiometabolic health solutions, click here. About Teladoc HealthTeladoc Health empowers all people everywhere to live their healthiest lives by transforming the healthcare experience. As the world leader in virtual care, Teladoc Health uses proprietary health signals and personalized interactions to drive better health outcomes across the full continuum of care, at every stage in a person’s health journey. Teladoc Health leverages more than two decades of expertise and data-driven insights to meet the growing virtual care needs of consumers and healthcare professionals. For more information, please visit www.teladochealth.com. Media: Lou SerioPR@teladochealth.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6d73b64d-10ae-44ab-a6c5-2994eadae02a

Hello Heart Unveils Connected Pill Box to Radically Improve Medication Adherence

MENLO PARK, Calif.–(BUSINESS WIRE)–Hello Heart, the digital leader in preventive heart health, today introduced Hello Heart Pill Box, a proprietary smart pill box designed to improve medication adherence. This addition to Hello Heart’s suite of heart health tools, including its blood pressure monitor and mobile app, addresses one of the most […]

Viz.ai Wins 2025 Edison Award™ for Machine Learning Innovation for the Third Consecutive Year

Honored for excellence and innovation in cardiovascular health diagnostics for Viz HCM module SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced that it has been named an Award Winner in the 2025 Edison Awards, for the third year in a row. Viz HCM, […]

Mesoblast Files Request for Type B Meeting with FDA to Discuss Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure

NEW YORK, April 02, 2025 (GLOBE NEWSWIRE) — Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on its plans to meet with the United States Food and Drug Administration (FDA) to discuss the accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation.

Breakthrough AI Indicator for HFpEF and Cardiotoxicity Added to Exo Iris®

Exo unveils its 10th FDA-cleared AI, delivering instant, on-device Global Longitudinal Strain (GLS) analysis — no cloud, no lag, no guesswork Identify signs of heart failure and cardiotoxicity SANTA CLARA, Calif.–(BUSINESS WIRE)–Exo (pronounced “echo”), the leader in AI-powered, accessible medical imaging, announced its latest FDA 510(k) clearance for Global Longitudinal Strain […]