Category: FDA

Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.

FDA Grants AI-Powered Notal Vision...

May 16, 2024

“We are very excited to receive FDA authorization to market SCANLY Home OCT as the first-ever patient self-operated, home-use device that gives physicians remote access to high-resolution, cross-sectional retinal images and AI-based analytical biomarkers of their patients eyes between office visits,” said Kester Nahen, PhD, CEO of Notal Vision. “We look forward to supporting our referring physicians in navigating their wet AMD patients’ care.”

Atraverse Medical Receives FDA Clearance...

May 15, 2024

The HOTWIRE system, invented by Atraverse Medical Co-Founders Dr. Steven Mickelsen and Eric Sauter, introduces a paradigm shift in left-heart access.

FDA Grants AI-Powered Notal Vision Home OCT “SCANLY” De Novo Marketing Authorization

May 16, 2024

FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments

FDA notes patients must have received at least two prior therapies before taking Trodelvy.

April 22, 2020

PROLIFT Lateral Fixated System Receives FDA Clearance

PROLIFT® Lateral Fixated System combines the innovation of the SENTRY® Lateral Plate with the technology of the Lateral PROLIFT Expandable System for a simplified Lateral procedure

April 21, 2020

FDA Authorizes First Test for Patient At-Home Sample Collection

"Throughout this pandemic, we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options," said FDA Commissioner Stephen M. Hahn, M.D.

April 21, 2020

FDA Grants NEXUS Aortic Arch Stent Graft System Breakthrough Designation

The designation of NEXUSTM Aortic Arch Stent Graft System as a breakthrough device acknowledges the unmet need in this patient population and the potential for improvements over current standard treatments.

April 20, 2020

U.S. FDA Grants Breakthrough Designation to CytoSorb for Removal of Ticagrelor During Cardiopulmonary Bypass in Emergent and Urgent Cardiothoracic Surgery

Through Breakthrough Designation, FDA will work with CytoSorbents to expedite the development, assessment, and regulatory review of CytoSorb for the removal of ticagrelor, while maintaining statutory standards of regulatory approval (e.g., 510(k), de novo 510(k) or premarket approval (PMA)) consistent with the Agency's mission to protect and promote public health.

April 20, 2020

FDA: Update on Serological Test Validation and Education Efforts

FDA notes as the country starts to see positive signs that the mitigation efforts, like stay-at-home orders and social distancing, are working in our fight against the COVID-19 pandemic, the question of when we can return to work and resume our normal activities is one of the most critical issues facing our nation.

April 19, 2020

FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2- Positive Metastatic Breast Cancer

The FDA collaborated with the Australian Therapeutic Goods Administration (TGA), Health Canada, Health Sciences Authority (HSA, Singapore) and Swissmedic (SMC, Switzerland) on this review.

April 17, 2020

First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer

Urothelial cancer is a cancer of the lining of the urinary system.

April 15, 2020

Stat Profile Prime Plus Analyzer Receives FDA Clearance for Point-of-Care Use: Reports Nova Biomedical

This clearance allows POC personnel to perform bedside critical care testing with lab-quality results in as little as one-minute notes Nova Biomedical.

April 15, 2020