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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.

Nanox Receives FDA Clearance for General Use of New Imaging System, Nanox.ARC X

First FDA clearance for Nanox.ARC X to produce tomographic images for general use, including musculoskeletal, pulmonary, intra-abdominal and paranasal indications. The enhanced imaging system features sleek design with smaller footprint; simplified ‘plug and play’ installation process and the system design enables software upgrades and new capabilities to be added remotely following future regulatory clearances

Medline Announces FDA Clearance for REFLEX HYBRID Nitinol Implants

Medline Announces FDA Clearance for REFLEX HYBRID Nitinol Implants for Foot and Ankle Surgery

“REFLEX HYBRID further demonstrates our commitment to offering innovative solutions for foot and ankle surgeons. The first to market product addresses gaps in the current competitive landscape, including offering indication specific designs, intraoperative compression, and intraoperative adjustment with a nitinol implant,” said Scott Goldstein, vice president of product management for Medline UNITE.

Terumo Neuro Receives FDA Approval for Carotid Stent System

This milestone marks the first dual-layer micromesh carotid stent approved in the United States, offering physicians a clinically proven option to improve patient outcomes in carotid artery disease treatment reports Terumo Neuro.

Phantom Neuro Receives FDA Breakthrough Device & TAP Designations, Solidifying Position as a Neurotech Leader

“Receiving both of these certified designations from the FDA is a tremendous validation of our work,” said Dr. Connor Glass, Founder and CEO of Phantom Neuro. “These recognitions validate our technology and reflect our commitment to creating scalable, real-world solutions that restore functionality and independence to amputees and those with functional disabilities. Our goal is to bring Phantom X to patients faster, and achievements like this accelerate our clinical and regulatory processes.”