SOUTHLAKE, Texas, July 11, 2023 /PRNewswire/ — Renibus Therapeutics, Inc., (“Renibus”), a clinical-stage biopharmaceutical company focusing on the prevention and treatment of cardio-renal diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to RBT-1 for the reduction in risk of post-operative complications in patients undergoing cardiothoracic […]
Regulatory
MedRhythms Announces FDA Listing of InTandem™ (MR-001) to Improve Walking and Ambulation in Adults with Chronic Stroke
Stroke is a leading cause of long-term disability, and over half of people aged 65 or older who have had a stroke experience reduced mobility and gait deficits PORTLAND, Maine, July 6, 2023 /PRNewswire/ — MedRhythms today announced that MR-001, the company’s evidence-based neurorehabilitation system to improve walking and ambulation in adults with chronic […]
BIOTRONIK Receives FDA Approval For Next-Generation Family of Pacemakers
The Amvia Edge pacemaker platform introduces always-on, automatic MR detection algorithm to fully streamline MRI workflow LAKE OSWEGO, Ore., July 6, 2023 /PRNewswire/ — BIOTRONIK today announced U.S. Food and Drug Administration (FDA) approval of its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P), its latest innovation in cardiac rhythm management. Amvia Edge, […]
ABBOTT RECEIVES FDA APPROVAL FOR WORLD’S FIRST DUAL CHAMBER LEADLESS PACEMAKER
Abbott’s breakthrough technology enables the world’s first beat-to-beat, wireless communication and synchronization between two leadless pacemakers, which are smaller than a AAA battery Leadless pacemakers provide a new minimally invasive option that will revolutionize care for more people in the U.S. who need pacing to treat a variety of slow […]
FEops Receives FDA Clearance for Its AI-Based Anatomical Analysis Capabilities
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 […]
Caristo Diagnostics Applauds FDA Approval of Colchicine as First Anti-Inflammatory Drug for Cardiovascular Disease
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 […]
BioCardia Announces FDA Completes Review of Proposed Adaptive Statistical Analysis Design for Ongoing CardiAMP Cell Therapy in Heart Failure Pivotal Study
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 […]
Anumana Receives U.S. FDA Breakthrough Device Designation for its Cardiac Amyloidosis Algorithm
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 […]
DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2/3 Trial For Ischemic Stroke
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 Receives FDA Approval for the SurVeil™ Drug-Coated Balloon
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 […]
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