TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System
A flowable bio-gel to protect healing tissue and preserve function.
June 9, 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.
FDA
FDA Grants De Novo Clearance for Reflow Medical’s Spur® Peripheral Retrievable Stent System
Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug Administration (FDA) has
May 30, 2025
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MSKai Spine Imaging Software Receives FDA 510(k) Clearance for Clinical Use
Advanced software tool supports consistent, objective evaluation of lumbar spine MRI scans.
May 22, 2025
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GC Biopharma Receives FDA Approval for its U.S. Plasma Collection Center in Calexico, California
With this approval, ABO Holdings is now operating all six plasma collection centers—two each in California, Utah, and New Jersey.
May 14, 2025
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Carr Tech Corp Celebrates FDA 510(k) Class II Approval of FROG All-in-One Filter Needle
This transformative device advances safety and efficiency in drug preparation, underscoring the startup’s journey from solo founder to FDA-cleared innovator.
April 25, 2025
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CereVasc’s eShunt® System Gains FDA Breakthrough Designation
“The recognition of Breakthrough Device Designation for the eShunt System in pediatric aged patients demonstrates the profound need for treatment innovation in this patient population and reinforces the potential safety and efficacy benefits that have already been observed with this minimally invasive, endovascular approach,” said Dan Levangie, Chairman & CEO of CereVasc, Inc. “We are encouraged and committed to making the eShunt System available to as many patients as possible living with this debilitating disease.”
April 23, 2025
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