Author: Ken Dropiewski

U.S. FDA Approves Broad New Labels for Esperion’s NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

ANN ARBOR, Mich.–(BUSINESS WIRE)–Esperion (NASDAQ: ESPR) today announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients. In addition, the enhanced labels support the use of NEXLET

TriSalus Life Sciences Announces Oral Presentations at the Upcoming 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting

DENVER–(BUSINESS WIRE)–TriSalus Life Sciences® Inc. (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, announced today that the Company will present data from recent research findings at the 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting, to be held March 23-28, 2024, in Salt Lake City, Utah. TriSalus will share data on the technical feasibility and saf

Elixir Medical Receives FDA Breakthrough Device Designation for the DynamX BTK System for Use in the Treatment of Chronic Limb-Threatening Ischemia Resulting From Below-The-Knee Arterial Disease

MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of disruptive technologies to treat cardiovascular and peripheral disease, today announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX® BTK System, a novel, adaptive implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The DynamX Bioadaptor platform is a medical technology d

Vista.ai Appoints MedTech Veteran Daniel Hawkins as Chief Executive Officer

PALO ALTO, Calif.–(BUSINESS WIRE)–VISTA.AI today announced the appointment of Daniel Hawkins as President and CEO. The company is pioneering AI-driven MRI image acquisition enabling any MRI technician to consistently produce high quality scans for complex indications quickly, efficiently and affordably. Daniel joins Vista.ai at a pivotal time following FDA clearance and confirmatory early commercialization of the company’s initial product focused on Cardiac MRI (CMR). Over time, the company p

AngioDynamics to Report Fiscal 2024 Third Quarter Financial Results on April 4, 2024

LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced that it will report financial results for the third quarter of fiscal year 2024 before the market open on Thursday, April 4, 2024. The Company’s management will host a conference call at 8:00 a.m. ET the same day to