NAPERVILLE, Ill., Oct. 9, 2023 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), announced it has received Investigational Device Exemption (IDE) approval from the FDA for a subsequent multicenter study, PROACTIVE-HF 2, which will evaluate the company’s Cordella Sensor for pulmonary artery […]
Coronary/Structural Heart
Late-Breaking Data Confirms Safety of Axon Therapies’ Innovative Heart Failure Procedure and Identifies Patients Most Likely to Benefit from SAVM Therapy
SANTA CLARA, Calif., Oct. 8, 2023 /PRNewswire/ — Axon Therapies, a private company focused on addressing a root cause of heart failure, today announced 6-month results of the REBALANCE-HF randomized, blinded feasibility trial of the Splanchnic Ablation for Volume Management (SAVM) procedure for heart failure with preserved ejection fraction (HFpEF). The main objectives of the […]
Marizyme, Inc. Announces FDA Clearance for Flagship Product, DuraGraft™
JUPITER, FL, Oct. 06, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Marizyme, Inc. (OTCQB:MRZM) (“Marizyme” or the “Company”), a global medical technology company focused on the development of products to address unmet clinical needs, today announced that it was granted a de novo from the U.S. Food and Drug Administration (FDA) for its […]
MedAxiom Recruits Test Sites for Peer Review Plus, World’s First Crowdsourced Clinical Performance and Case Evaluation Solution
NEPTUNE BEACH, Fla.–(BUSINESS WIRE)–MedAxiom, the cardiovascular community’s premier destination for organizational performance solutions, has developed Peer Review Plus™, the world’s first clinical peer review solution to effectively and efficiently conduct unbiased performance evaluations and case reviews with input from a nationwide network of peers. MedAxiom is currently recruiting healthcare organizations […]
Elixir Medical To Present Randomized Clinical Dataset Featuring World’s First Triple Drug-Eluting Coronary Implant Eluting Two Anticoagulants and Sirolimus at TCT 2023
MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of innovative cardiovascular technologies, announced it will present primary endpoint and 6-month data from its DESyne BDS Plus Randomized Clinical Trial (RCT), a prospective, multicenter, single-blind study, as part of The Innovation Program at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. The data […]
Millar to Unveil Revolutionary Chronic Pressure Measurement Platform at MD&M Minneapolis
HOUSTON, Oct. 5, 2023 /PRNewswire/ — Millar, OEM solutions partner and leader in MEMS pressure sensor integration, is thrilled to announce that it will officially unveil its groundbreaking chronic pressure measurement technology platform, TiSense, at the upcoming MD&M tradeshow in Minneapolis on October 10-11, 2023. This event serves as the perfect stage for Millar to introduce TiSense […]
Elixir Medical Completes Submission of DynamX Coronary Bioadaptor System to Japan’s PMDA Agency for Regulatory Approval
MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of disruptive cardiovascular technologies, announced submission to Japan’s Pharmaceutical and Medical Device Agency (PMDA) for the approval of the DynamX® Coronary Bioadaptor System for the treatment of coronary artery disease (CAD). DynamX coronary bioadaptor was developed to overcome the limitations of drug-eluting stents (DES) and […]
FineHeart Obtains Czech Health Authority Approval to Commence First in Human Clinical Study
BORDEAUX, France–(BUSINESS WIRE)–FineHeart S.A, a medical device company developing innovative devices for cardiology announced today that it has received authorization from the SUKL (the Czech Republic State Institute for the Control of Medicinal Products) to carry out “A prospective, single arm, single center, First in Human Study to evaluate the […]
SS Innovations Launches Innovative Robotic Cardiac Surgery Program in India
FORT LAUDERDALE, FL, Oct. 03, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announces the launch of an innovative robotic cardiac surgery program […]
FDA Grants Breakthrough Device Designation to SeaStar Medical’s Selective Cytopheretic Device for Cardiorenal Syndrome
DENVER, Sept. 29, 2023 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces receipt of U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) for use with patients in the hospital […]



