Coronary/Structural Heart

Cleerly® ISCHEMIA™ Software Device Billable With AMA Category I CPT® Code for Noninvasive Estimates of Fractional Flow Reserve

DENVER–(BUSINESS WIRE)–Cleerly, the company creating a new standard of care to aid in the diagnosis of heart disease, announced that its recently U.S. Food and Drug Administration (FDA)-cleared Cleerly ISCHEMIA software device applied to a non-invasive coronary CT angiogram (CCTA) can be billed using the new Category I CPT® code 75580. The American […]

PrepMD Partners with MediaSphere and Esteemed Cardiac Experts for Groundbreaking Virtual Device Clinic Leadership Summit

BRAINTREE, Mass., Feb. 21, 2024 /PRNewswire/ — PrepMD, as the exclusive sponsor, is thrilled to announce its partnership with MediaSphere and distinguished cardiac professionals, including Beth Davenport and Sallie Gustafson, to present the largest-ever virtual accredited Cardiac Device…

Saghmos Therapeutics Announces Appointment of FDA Veteran Stephen Grant, MD, as Chief Regulatory Officer

GREENWICH, Conn.–(BUSINESS WIRE)–Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced the appointment of Stephen Grant, MD, as Chief Regulatory Officer. Dr. Grant was the former Deputy Director, Division of Cardiology and Nephrology at the FDA. During his more than 20-year career at the FDA, he was responsible for […]

BiVACOR® Receives $13 Million to Support Clinical Trials for the Company’s Total Artificial Heart

GOLD COAST, Australia & HUNTINGTON BEACH, Calif.–(BUSINESS WIRE)–BiVACOR®, a clinical-stage medical device company, today announced $13 million (USD) awarded from the Australian Government’s Medical Research Future Fund (MRFF) grant through the Artificial Heart Frontiers Program (AHFP) to support BiVACOR’s Total Artificial Heart program and future product enhancements. Led by Monash […]

Reprieve Cardiovascular Emerges from Stealth Mode after $42 Million Series A Financing to Bring Intelligent Fluid Management to Heart Failure Patients

MILFORD, Mass.–(BUSINESS WIRE)–Reprieve Cardiovascular, Inc., a development stage company focused on pioneering an intelligent automated diuretic and fluid management approach for acute decompensated heart failure (ADHF) treatment, today announced it has raised a total of $42 million in series A financing. The total round was co-led by Lightstone Ventures and […]

Vaxxinity’s Cholesterol Vaccine Candidate Successfully Lowers LDL-C: Preclinical Data Published

Preclinical data published in the Journal of Lipid Research indicate VXX-401 is well-tolerated, with no safety signals observed, and robustly reduces LDL-C in cynomolgus monkeys. A Phase 1 trial of VXX-401 is ongoing, with topline results expected mid-2024. CAPE CANAVERAL, Fla., Feb. 15, 2024 (GLOBE NEWSWIRE) — Vaxxinity, Inc. (Nasdaq: […]

4DMT Presents Interim Data from 4D-310 INGLAXA Phase 1/2 Clinical Trials for Fabry Disease Cardiomyopathy at WORLDSymposium™ 2024

4D-310 demonstrated clinically meaningful cardiac endpoint improvements through 12-24 months in contractility (echocardiography), peak VO2 (cardiopulmonary exercise testing) and/or cardiac quality of life (KCCQ) in all five evaluable patients Cardiac biopsies were obtained from a patient at week 6 and 24 and showed robust and durable delivery, transgene expression and […]

Cleerly® Announces CERTAIN Multicenter Clinical Trial Results

Study Results Demonstrate the Prominent Effects of Cleerly’s Products on Changing Clinical Management for Patients Suspected of Coronary Artery Disease DENVER – February 8, 2024 — Cleerly, the company working to create a new standard of care to aid in the diagnosis of heart disease, announced continued strong scientific evidence supporting […]

BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA

SUNNYVALE, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. (“BioCardia” or the “Company”) (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, is targeting heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates: autologous CardiAMP® cell therapy and allogeneic CardiALLO™ […]

Nudj Health Expands Virtual Cardiac Rehab Services to Patients with Ornish Lifestyle Medicine by Sharecare

PASADENA, Calif., Feb. 06, 2024 (GLOBE NEWSWIRE) — Nudj Health, a tech-enabled health service that delivers evidence-based mental health and lifestyle interventions, today announced the launch of their new Nudj Cardiac Complete™ program, which features exclusive, Medicare-approved Virtual Intensive Cardiac Rehab (v-ICR) along with evidence-based Collaborative Care. Nudj Cardiac Complete, […]