HOUSTON–(BUSINESS WIRE)–Saranas, Inc. announced today the compelling results of SAFE-MCS, a multi-center clinical study evaluating the safety of complex high-risk percutaneous coronary intervention (PCI) using mechanical circulatory support (MCS) and surveillance with the Early Bird® Bleed Monitoring System (EBBMS). Dr. Babar Basir, Director of Acute Mechanical Circulatory Support, at Henry Ford Health System and co-principal investigator of SAFE-MCS, presented “The Safe Surveillance of Percu
Coronary/Structural Heart
PulseCath Achieves MDR CE Certification for iVAC 2L, Paving the Way for Complex High-Risk Percutaneous Coronary Interventions
ARNHEM, Netherlands, March 11, 2024 /PRNewswire/ — PulseCath B.V., a leader in the expanding field of percutaneous ventricular assist devices for high-risk PCI, proudly announces the successful achievement of the transition from Medical Device Directive (MDD) CE marking to Medical Device…
United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD)
NEW YORK, March 10, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection […]
Wegovy® receives FDA approval for cardiovascular risk reduction in adults with known heart disease and overweight or obesity
Wegovy® (semaglutide) injection 2.4 mg is the first-and-only medicine indicated for both reduction of the risk of major adverse cardiovascular events (MACE) such as death, heart attack, or stroke and for long-term weight management1 The approval is based on the results of SELECT, the…
Getinge takes a leap forward in cardiovascular surgery with the 510(k) clearance for Vasoview Hemopro 3
GOTHENBURG, Sweden, March 8, 2024 /PRNewswire/ — Today, Getinge announces the U.S. Food and Drug Administration’s (FDA) 510(k) clearance of the Vasoview Hemopro 3, the latest addition to the medtech company’s endoscopic vessel harvesting (EVH) solutions. Designed with customer centricity…
Arch Biopartners Announces Dosing of First Patient in Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury
TORONTO, March 07, 2024 (GLOBE NEWSWIRE) — Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury […]
UltraNav Transseptal System will present at “Best Interesting Case” at CRT
Unique new dual-lumen catheter enables safer, more cost-effective transeptal crossing and left atrial access, improving cardiologist and patient experience; CRT “Best Interesting Case” highlights left appendage closure device implantation without the need for TEE or anesthesia SCOTTSDALE, Ariz., March 5, 2024 /PRNewswire/ — Franklin Mountain Medical announced today that the Dib UltraNav Transseptal […]
Cleerly® Receives FDA Breakthrough Device Designation for Heart Disease Risk Staging System
DENVER–(BUSINESS WIRE)–Cleerly, the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System. The CAD Staging System is a […]
Cardio Diagnostics Holdings, Inc. Announces Issuance of Second U.S. Patent for Compositions and Methods for Detecting Predisposition to Cardiovascular Disease
CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), an AI-driven precision cardiovascular medicine company, announces that the U.S. Patent and Trademark Office has issued a notice of allowance to University of Iowa Research Foundation (“UIRF”) for U.S. Application No. 17,857,723 titled Compositions and Methods for Detecting Predisposition to Cardiovascular Disease, which is […]
Boston Scientific Receives FDA Approval for the AGENT™ Drug-Coated Balloon
First coronary drug-coated balloon in U.S. provides safe, effective alternative to treat coronary in-stent restenosis and reduce risk of reoccurrence MARLBOROUGH, Mass., March 1, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and…



