Coronary/Structural Heart

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 […]

U.S. Food and Drug Administration Approves Addition of Positive Data from Phase 3 VALOR-HCM Study to CAMZYOS® (mavacamten) Label

CAMZYOS is the first and only FDA-approved cardiac myosin inhibitor that specifically targets the underlying source of obstructive HCM VALOR-HCM is the second Phase 3 trial in which CAMZYOS demonstrated significant improvement in symptoms of obstructive HCM June 15, 2023 08:23 PM Eastern Daylight Time PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced […]

Verve Establishes Global Collaboration with Lilly to Advance Verve’s In Vivo Gene Editing Program Targeting Lp(a) for the Treatment of Atherosclerotic Cardiovascular Disease

Verve to Receive $60 Million in Combined Upfront Payment and Equity Investment; Additional Capital Positioned to Extend Verve’s Expected Cash Runway into 2026 Verve has Opt-in Rights to Co-fund and Share in Potential Margins of Products Resulting from the Collaboration BOSTON, June 15, 2023 (GLOBE NEWSWIRE) — Verve Therapeutics, Inc. […]

CytoSorbents Announces Independent Data Safety and Monitoring Board Recommends Completion of the Pivotal STAR-T Trial Without Modifications Following Second Scheduled Safety Review

PRINCETON, N.J., June 15, 2023 (GLOBE NEWSWIRE) — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has received the recommendation from the independent Data and Safety Monitoring Board […]