Coronary/Structural Heart

HeartFlow Files for FDA Clearance of Next Generation Product Offering to Help Evaluate the Presence of Narrowings and Plaque in the Coronary Arteries

Advanced innovations leverage HeartFlow’s core AI technology and are critical additions to HeartFlow’s product portfolio for delivering complete cardiac care REDWOOD CITY, Calif., Dec. 13, 2021 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced it has submitted a 510k premarket application to the U.S. Food […]

MindMics Announces Successful Clinical Studies with Scripps Health

The new cardiac function studies demonstrate precise medical results with the technology in the form of a consumer wearable BOSTON–(BUSINESS WIRE)–MindMics, the actionable health monitoring company, today, announced the results of two ground-breaking studies reported by Scripps Health at the American Heart Association. Both results demonstrate the effectiveness of MindMics’ technology – Infrasonic […]

Angion and Vifor Pharma Report Topline Results from Phase 2 GUARD Trial of ANG-3777 in Cardiac Surgery-Associated Acute Kidney Injury

— Angion to host a conference call today at 4:30 p.m. EST UNIONDALE, N.Y. and ST. GALLEN, Switzerland, Dec. 09, 2021 (GLOBE NEWSWIRE) — Angion Biomedica Corp. (NASDAQ:ANGN) and Vifor Pharma today announced results from the exploratory Phase 2 GUARD trial of Angion’s ANG-3777 in patients undergoing cardiac surgery involving […]

Prestigious annual pediatric medical device competition takes aim at congenital heart disease with five innovators sharing $150K in NCC-PDI grants

Washington D.C., Dec. 10, 2021 (GLOBE NEWSWIRE) — The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces five awardees chosen in its prestigious annual “Make Your Medical Device Pitch for Kids!” competition to share $150,000 in grant funding from the U.S. Food and Drug Administration (FDA) to support the advancement of […]

Cytokinetics Announces Receipt of Breakthrough Therapy Designation from FDA for Aficamten

FDA Granted Designation for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy Based on Results of REDWOOD-HCM SOUTH SAN FRANCISCO, Dec. 09, 2021 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for aficamten for the treatment of symptomatic obstructive […]

Venus Medtech Acquires Cardiovalve to Optimize its Innovative Products Pipeline of Mitral and Tricuspid Valve Replacement

HANGZHOU, China, Dec. 7, 2021 /PRNewswire/ — Venus Medtech (Hangzhou) Inc. (Venus MedTech, 2500.HK), a leading, innovative Chinese structural heart disease treatment company, announced its acquisition of Cardiovalve Ltd. (Cardiovalve), a pioneering transcatheter mitral and tricuspid valve treatment company on December 7th, 2021. Venus Medtech will acquire 100% equity interest and corresponding equity […]

Donisi Health Takes Home First Place in the Prestigious Innovations in Cardiovascular Intervention Competition

MedTech Startup Focused on Home Monitoring for Patients with Congestive Heart Failure and Other Chronic Diseases Wins the 2021 ICI Pitch Competition and $200,000 Award TEL AVIV, Israel, Dec. 8, 2021 /PRNewswire/ — Donisi Health (Donisi) prevailed in this year’s ICI Innovation Competition – the premier international conference for innovations in cardiovascular intervention. Competing against […]

Sequana Medical announces positive interim results of SAHARA DESERT, the alfapump DSR® study in heart failure patients with persistent congestion

Interim data from six patients indicate that alfapump DSR therapy can: safely, effectively and rapidly eliminate persistent congestion and restore euvolemia in diuretic-resistant heart failure patients, considerably benefit cardio-renal status, and dramatically improve diuretic responsiveness for months post–treatment Recruitment on–track to report top–line data in H2 2022 Long-term follow-up of RED DESERT patients shows durable improvement in diuretic response following alfapump DSR therapy Proprietary DSR Infusate 2.0 development on track to start MOJAVE […]

Foldax Receives Approval for Clinical Trial of TRIA Biopolymer Surgical Aortic Heart Valve in India

SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the Drugs Controller General of India (DCGI), India’s regulatory body for medical devices, has approved initiation of a clinical trial of the TRIA™ biopolymer surgical aortic heart valve. The TRIA valve reimagines the heart valve by combining the company’s proprietary biopolymer – […]

Restore Medical Announces First in Human Trial for Treatment of Heart Failure in Patients

ContraBand™ technology helps restore the heart’s functionality and may significantly improve patients’ quality of life OR YEHUDA, Israel, Dec. 7, 2021 /PRNewswire/ — Restore Medical Ltd., a clinical-stage MedTech company developing cardiac implants for the treatment of congestive heart failure (CHF), today announced promising preliminary results of the First-in-Human clinical trial of ContraBand™, a breakthrough treatment […]