Regulatory

Ultragenyx Receives Positive Recommendation from NICE in the U.K. for Evkeeza® ▼ (evinacumab) for Adolescents and Adults Aged 12 Years and Older with Homozygous Familial Hypercholesterolemia (HoFH)

NOVATO, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending Evkeeza® (evinacumab) to NHS England. Evkeeza is recommended […]

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 […]

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 […]

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 […]

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 […]

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 […]

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. […]

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 […]

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 […]