The Latest Cardiac and Vascular News
Enabling a time-efficient workflow and better-informed clinical decision making for structural heart interventions GENT, Belgium–(BUSINESS WIRE)–FEops announced today its new release of FEops HEARTguide™, including an AI-based anatomical analysis of MSCT images for the pre-operative planning of structural heart interventions. With this introduction, physicians don’t need to do the measurements […]
Colchicine’s Approval Heightens the Need for Technologies Detecting Inflammation Specifically Related to Coronary Arteries OXFORD, England, June 22, 2023 /PRNewswire/ — Caristo Diagnostics Limited, a global leader in cardiac and vascular disease diagnostics and risk prediction, applauds the FDA’s decision to approve colchicine as first anti-inflammatory drug for cardiovascular disease. Caristo reaffirms its commitment […]
SUNNYVALE, Calif., June 20, 2023 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that FDA Center for Biologics Evaluation and Research (CBER) has completed review of the CardiAMP Cell Therapy System adaptive statistical analysis design supplement […]
Developed in collaboration with Mayo Clinic, with support from Pfizer, this ECG-AI algorithm aims to aid physicians in earlier identification of cardiac amyloidosis CAMBRIDGE, Mass.–(BUSINESS WIRE)–Anumana, Inc., a leading AI-driven health technology company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its ECG-AI algorithm […]
MINNEAPOLIS–(BUSINESS WIRE)–DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold placed on the investigational new drug application for its ReMEDy2 phase 2/3 clinical trial […]
Surmodics to receive $27 million milestone payment from Abbott EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced the receipt of U.S. Food and Drug Administration (FDA) approval for the SurVeil™ drug-coated balloon (DCB). The […]
LODOCO® (colchicine, 0.5 mg tablet) Reduces Cardiac Event Risk in Adult Patients with Established Atherosclerotic Cardiovascular Disease (ASCVD) by an Additional 31% on Top of Standard of Care. LODOCO Targets Residual Inflammation as an Underlying Cause of ASCVD and Can be Used Alone or in Combination with Cholesterol-Lowering Medications PARSIPPANY, N.J.–(BUSINESS WIRE)–AGEPHA Pharma […]
LEHI, Utah–(BUSINESS WIRE)–Owlet (NYSE: OWLT, “the Company”), the pioneer of smart baby monitoring, announces clearance from the U.S. Food and Drug Administration (“FDA”) of BabySat™, the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Owlet is a leader in infant health data, having monitored more than 1 million babies, and […]
SAN FRANCISCO–(BUSINESS WIRE)–The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients […]
CAMZYOS is the first and only FDA-approved cardiac myosin inhibitor that specifically targets the underlying source of obstructive HCM VALOR-HCM is the second Phase 3 trial in which CAMZYOS demonstrated significant improvement in symptoms of obstructive HCM June 15, 2023 08:23 PM Eastern Daylight Time PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced […]
