Mursla Bio Receives FDA Breakthrough Device Designation for EvoLiver Test
Reflects the potential of EvoLiver test to improve early liver cancer detection among high-risk patients
April 23, 2025
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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
April 17, 2025
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FDA
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.
April 16, 2025
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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.
April 15, 2025
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U.S. FDA Grants Paige Breakthrough Device Designation for AI Application that Detects Cancer Across Different Anatomic Sites
Paige PanCancer Detect recognized by FDA as a Breakthrough Device intended to assist pathologists in the detection of cancer across multiple tissue and organ types.
April 3, 2025
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restor3d Receives FDA Clearance for iTotal IdentityTM CR 3DP Porous Fully Personalized Total Knee Replacement System
This milestone marks a significant achievement in expanding restor3d’s knee replacement technology since the acquisition of Conformis, introducing the first cementless offering to the patient-specific implant portfolio. The company plans a limited market release in Q3 of 2025.
April 1, 2025
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