TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) — Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated […]
Regulatory
Biosense Webster Announces Regulatory Approval of VARIPULSE™ Pulsed Field Ablation (PFA) Platform in Japan
First regulatory approval for the first-of-its-kind, fully-integrated PFA system with a simple and reproducible workflow Integrated with the world’s leading CARTO™ 3D cardiac mapping system for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AFib)…
American Medical Association (AMA) Grants Cardio Diagnostics Holdings, Inc.’s AI-Powered Coronary Heart Disease Detection Test, PrecisionCHD, a Dedicated CPT PLA Reimbursement Code
CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc. (Nasdaq: CDIO), an AI-driven precision cardiovascular medicine company, today announced that the American Medical Association (AMA) has assigned a dedicated Current Procedural Terminology (CPT®) Proprietary Laboratory Analysis (PLA), 0440U, for the company’s AI-driven coronary heart disease (CHD) detection test, PrecisionCHD. Receipt of this new CPT […]
Pulse Biosciences Files 510(k) Submission with U.S. FDA for its CellFX® nsPFA™ Cardiac Clamp
HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, today announced the filing of a premarket notification 510(k) to the U.S. Food and Drug Administration (FDA) for its novel […]
Renibus Therapeutics Announces Breakthrough Therapy Designation from US FDA for RBT-1 for the Reduction in Risk of Post-Operative Complications in Patients Undergoing Cardiothoracic Surgery
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 […]
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 […]
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