Other News

Centerline Biomedical receives FDA 510(k) clearance for new IOPS® Viewpoint Catheter, further addressing market need to reduce physician exposure to harmful x-ray radiation during image-guided, endovascular procedures

CLEVELAND, Aug. 6, 2024 /PRNewswire/ — Centerline Biomedical, Inc. (“Centerline”), an innovation leader in cardiovascular navigation and visualization systems, announced today that the IOPS Viewpoint Catheter has received US Food and Drug Administration (FDA) 510(k) clearance. The…

Leading Cardiac Diagnostics Innovator Zywie Announces Industry Partnership With MedAxiom

ATLANTA–(BUSINESS WIRE)–Zywie, a cardiovascular diagnostics pioneer specializing in remote cardiac monitoring through wearable biosensor devices and cloud-based data analytic solutions, announced today a partnership with MedAxiom, the cardiovascular community’s premier source for organizational performance solutions. “We are proud to welcome Zywie to the MedAxiom community” Post this “We are proud to welcome Zywie to the […]

Tenax Therapeutics Announces Oversubscribed $100 Million Private Placement

CHAPEL HILL, N.C., Aug. 06, 2024 (GLOBE NEWSWIRE) — Tenax Therapeutics, Inc. (Nasdaq: TENX) (the “Company” or “Tenax Therapeutics”), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that it has entered into a securities purchase agreement for an oversubscribed private placement financing that is expected to result in total gross proceeds of approximately $100 million to the Company, before deducting placement agent fees and other private placement expenses.

Sirtex Medical Launches SIR-Spheres® FLEXdose SELECT Delivery Program to Enable More Selective Y-90 Treatment Plans

WOBURN, Mass., Aug. 5, 2024 /PRNewswire/ — Sirtex Medical (“Sirtex”), a leading manufacturer of interventional treatment solutions, announced today the launch of its SIR-Spheres® FLEXdose SELECT Delivery Program, an innovative, new way to offer precise Y-90 selective internal radiation therapy for the treatment of metastatic colorectal cancer.   SIR-Spheres® FLEXdose SELECT Delivery Program offers unparalleled flexibility by […]

Bayer Announces Primary Endpoint Achieved in Phase III FINEARTS-HF Cardiovascular Outcomes Study Investigating KERENDIA® (finerenone) in Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction

FINEARTS-HF met its primary endpoint,1 achieving a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) heart failure (HF) events, defined as hospitalizations for HF or urgent HF visits 2 KERENDIA is the first non-steroidal, selective mineralocorticoid receptor antagonist (MRA) to meet a primary cardiovascular endpoint in […]

German Medtech Protembis Gets €20 Million EIB Backing for Technology to Protect Brain During Heart Treatment

July 30, 2024 01:00 AM Eastern Daylight Time LUXEMBOURG & AACHEN, Germany–(BUSINESS WIRE)–The European Investment Bank (EIB) is providing €20 million in venture-debt financing to German medical-technology company Protembis to develop a next-generation device for protecting the brains of patients who undergo certain heart treatments. “This agreement demonstrates our commitment […]

Adagio Medical Announces the Closing of the Business Combination with ARYA IV, Creating a Publicly Traded Company Focused on the Innovative Technologies for Treatment of Cardiac Arrhythmias

July 31, 2024 04:01 PM Eastern Daylight Time LAGUNA HILLS, Calif. & NEW YORK–(BUSINESS WIRE)–Adagio Medical, Inc. (“Adagio Medical”), a leading innovator in catheter ablation technologies for treatment of cardiac arrhythmias, announced today the completion of its business combination with ARYA Sciences Acquisition Corp IV (Nasdaq: ARYD; or “ARYA IV”), […]

Attralus Receives Breakthrough Therapy Designation for its Pan-Amyloid Diagnostic PET Imaging Candidate 124I-evuzamitide (AT-01) for Cardiac Amyloidosis

BURLINGAME, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) — Attralus, Inc., a clinical stage biopharmaceutical company developing transformative products to improve the lives of patients with systemic amyloidosis, today announced that its investigational diagnostic imaging agent drug, 124I-evuzamitide (AT-01), has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for positron emission tomography (PET) imaging in patients with suspected or known cardiac amyloidosis. FDA granted BTD for 124I-evuzamitide (AT-01) based on clinical data from Attralus-sponsored and investigator-initiated studies evaluating the use of 124I-evuzamitide in patients with cardiac amyloidosis, representing experience in more than 200 trial participants.