Other News

CEUS Underutilization May Pose Greater Risk Than Rare Side Effects Associated With Use, Say Experts

CHICAGO–(BUSINESS WIRE)–Contrast enhanced ultrasound (CEUS) is underutilized in the United States, and reduced access to this noninvasive diagnostic imaging tool may pose a greater risk to patients than rare side effects associated with use, according to doctors who spoke today at the 37th International Bubble Conference in Chicago. “CEUS cardiac exam […]

Positron Corporation Announces Start of Clinical Study of Affinity PET-CT Device

Niagara Falls, NY, Sept. 08, 2023 (GLOBE NEWSWIRE) — Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a leading molecular imaging medical device company, is pleased to announce that the Company will begin its clinical study of its Affinity™ PET-CT imaging device with Ochsner Clinic Foundation in New Orleans, LA. […]

Shape Memory Medical Receives FDA IDE Approval to Initiate AAA-SHAPE, a Head-to-Head Trial

SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced that the Food and Drug Administration (FDA) granted investigational device exemption (IDE) for the company to begin a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device […]

Endologix announces the U. S. Centers for Medicare & Medicaid Services granted a New Technology Add-on Payment for the DETOUR System

IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announces that the U. S. Centers for Medicare & Medicaid Services (CMS) granted a New Technology Add-on Payment (NTAP) for the DETOUR System, an FDA-designated Breakthrough Device, […]

Procyrion Secures New Medicare Payment Codes Applicable to its Aortix™ Percutaneous Mechanical Circulatory Support Technology

HOUSTON, Sept. 7, 2023 /PRNewswire/ — Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac and renal impairment, announced today it has successfully secured new inpatient hospital ICD-10-PCS procedure codes applicable to its Aortix™ percutaneous mechanical circulatory support (pMCS) technology. The new codes represent a significant milestone as […]

Gradient Denervation Technologies closes €14m Series A led by Sabadell Asabys

PARIS–(BUSINESS WIRE)– Gradient Denervation Technologies (“Gradient”), a medical device company developing an innovative catheter-based solution for the treatment of pulmonary hypertension, announces today the successful closing of a €14m Series A financing that will support ongoing clinical development and evaluation of the ultrasound-based catheter device. Asabys Partners led the round through its […]

GE HealthCare and Mass General Brigham Collaborate on an AI Algorithm to Predict Missed Care Opportunities

CHICAGO–(BUSINESS WIRE)–GE HealthCare and Mass General Brigham announced, as part of its initial collaboration, the co-development of an artificial intelligence (AI) algorithm that will help increase operations effectiveness and productivity. The first innovative AI application from the collaboration is the schedule predictions dashboard of Radiology Operations Module (ROM), a digital […]

HighLife Launches a New Large Annulus Valve in Ongoing Clinical Studies for Patients Suffering From Mitral Regurgitation

PARIS–(BUSINESS WIRE)–HighLife SAS, a medtech company focused on the development of a novel Trans-Septal Mitral Valve Replacement (“TSMVR”) system to treat patients suffering from moderate to severe mitral regurgitation (MR), announced today the introduction of a new valve size in its clinical trials, the Large Annulus Valve (LAV), designed for […]

Elucid Appoints Windi Hary to Lead Regulatory Affairs and Quality Management

BOSTON–(BUSINESS WIRE)–Elucid, Inc., a leading medical technology company providing physicians with AI-powered imaging analysis software to assess cardiovascular disease, has hired Windi Hary as senior vice president (SVP) of regulatory affairs and quality management. Windi’s vast, global experience in software-as-a-medical device (SaMD) and AI-enabled digital health will be central to […]