Saturday, July 13, 2024

CATEGORY

FDA

Surgical Procedures Revolutionized by ImmersiveTouch’s FDA-Cleared AR System

Surgical procedures benefit from ImmersiveTouch's U.S. Food and Drug Administration (FDA) clearance of its augmented reality (AR) system, designed to enhance craniomaxillofacial surgeries and...

Lung Cancer Breakthrough: Bayer’s BAY 2927088 Receives Breakthrough Therapy Designation in China

Lung cancer patients with HER2 activating mutations are focusing on Bayer's BAY 2927088, an oral small molecule tyrosine kinase inhibitor, as a potential breakthrough...

Lab-Developed Tests Face Regulatory Changes Following Supreme Court’s Overturn of Chevron Doctrine

Test regulations including those of the Food and Drug Administration (FDA) on lab-developed tests (LDTs), are set to be significantly impacted by the recent...

Endotracheal Tubes Recalled by Medtronic Due to Blockage Risk

Endotracheal tubes manufactured by Medtronic have been flagged by the Food and Drug Administration (FDA), which has instructed healthcare providers to cease using two...

Insulin Icodec Receives FDA Complete Response Letter, Additional Data Required for Approval

Insulin icodec a once-weekly basal insulin intended for the treatment of diabetes mellitus, has received a Complete Response Letter (CRL) from the Food and...

BD Bactec Blood Culture Media Bottles Added to FDA’s Medical Device Shortage List Due to Supply Issues

Blood culture media bottles from BD Life Sciences Bactec have been added to the Food and Drug Administration's (FDA) Medical Device Shortage List due...

Clinical Data Request from FDA Halts Pulse’s 510(k) Submission for PFA Device

Clinical data requirements have led Pulse Biosciences to announce its plan to switch from the 510(k) pathway to pursuing premarket approval (PMA) for its...

Atopic Dermatitis Breakthrough: FDA Approves Arcutis’s Zoryve for Atopic Dermatitis

Atopic dermatitis (AD), a prevalent form of eczema, has seen a new treatment approval with Arcutis Biotherapeutics successfully securing the U.S. Food and Drug...

Clinical Trials Diversity: FDA Pushes Concrete Plans for Greater Inclusion

Clinical trials are set to become more diverse as the Food and Drug Administration (FDA) has taken significant steps by releasing a comprehensive draft...

Cardiac Ablation Procedures: FDA Approves Cordis’ Vascular Closure Device

Cardiac ablation procedures will benefit from the US Food and Drug Administration's (FDA) approval of Cordis' Mynx Control VenousVascular Closure Device (VCD), which is...

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