Coronary/Structural Heart

Cleerly Wins 2023 Artificial Intelligence Breakthrough Award

Prestigious International Annual Awards Program Honors Standout AI and Machine Learning Solutions and Companies DENVER–(BUSINESS WIRE)–Cleerly, the company creating a new standard of care for heart disease, today announced that it has been named “Best Overall AI Solution” in the sixth annual AI Breakthrough Awards program conducted by AI Breakthrough, a […]

Nuwellis Inc. Announces Pilot Agreement With DaVita Inc.

Supply Agreement to Pilot Ultrafiltration Therapy Services Offering in Select Markets MINNEAPOLIS, June 20, 2023 (GLOBE NEWSWIRE) — Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced it has entered into a Supply and Collaboration Agreement with DaVita Inc. […]

Cytokinetics Announces Start of MAPLE-HCM, a Phase 3 Clinical Trial of Aficamten Compared to Metoprolol in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

First Phase 3 Trial Evaluating Monotherapy with a Cardiac Myosin Inhibitor Compared to Monotherapy with a Beta Blocker in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy SOUTH SAN FRANCISCO, Calif., June 20, 2023 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), a […]

U.S. FDA Approves First Anti-Inflammatory Drug for Cardiovascular Disease

LODOCO® (colchicine, 0.5 mg tablet) Reduces Cardiac Event Risk in Adult Patients with Established Atherosclerotic Cardiovascular Disease (ASCVD) by an Additional 31% on Top of Standard of Care. LODOCO Targets Residual Inflammation as an Underlying Cause of ASCVD and Can be Used Alone or in Combination with Cholesterol-Lowering Medications PARSIPPANY, N.J.–(BUSINESS WIRE)–AGEPHA Pharma […]

Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants

LEHI, Utah–(BUSINESS WIRE)–Owlet (NYSE: OWLT, “the Company”), the pioneer of smart baby monitoring, announces clearance from the U.S. Food and Drug Administration (“FDA”) of BabySat™, the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Owlet is a leader in infant health data, having monitored more than 1 million babies, and […]

Mallinckrodt Announces Publication of Real-World Data on the Use of Extracorporeal Photopheresis (ECP) in Heart Transplant Patients

– Results from the largest European and first multicenter, retrospective, observational chart review study investigating the real-world use of ECP in heart transplant patients reinforce its use as a treatment for heart transplant rejection and prevention of rejection1 – DUBLIN, June 19, 2023 /PRNewswire/ — Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today […]

Novel Transcatheter Valve Repair Device: DRAGONFLY-DMR 12-Month Trial Results Revealed at EuroPCR 2023

First-Time Clinical Trial Outcomes Show Promising Follow-Up Results HANGZHOU, China, June 19, 2023 /PRNewswire/ — On May 17th, the 12-month results of the DRAGONFLY-DMR pivotal trial were presented at EuroPCR 2023. This trial was led by Professor Jian’an Wang from Zhe’er Hospital, Hangzhou, China, and presented on his behalf by the Eligibility Committee Chair, […]

FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc. (Japan) – Enhance Cardiovascular Diagnostic Accuracy

SAN FRANCISCO–(BUSINESS WIRE)–The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients […]

Sequana Medical wins Best Technology Award for alfapump® at European Mediscience Awards

Ghent, Belgium – 16 June 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical”), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that its alfapump has won the ‘Best Technology’ Award at the European Mediscience Awards in […]

Esperion Presents Results from New Analysis on Cardiovascular Benefits with Bempedoic Acid Treatment at ENDO 2023

Cardiovascular risk reduction with bempedoic acid shown via the Cholesterol Treatment Trialists’ (CTT) Major Vascular Event endpoint is comparable to the normalized risk reduction with statins observed in the CTT meta-analyses ANN ARBOR, Mich., June 15, 2023 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) today presented results from an analysis comparing […]