Regulatory
Check out the latest Regulatory news being talked about today across the world.
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Mainstay Medical Announces Receipt of European and Australian Approvals of MRI Labeling on ReActiv8® Restorative Neurostimulation System™
MRI clearances received in connection…
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Orthofix Announces 510(k) Clearance and First Implant of Fitbone Transport and Lengthening System
LEWISVILLE, Texas, July 9, 2024–(BUSINESS…
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Legislation to grant 4-year coverage of breakthrough medical devices passes Ways and Means, with a heavy discount
By Emma Beavins July 2, 2024 –…
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Arkansas sues Optum, Express Scripts and others over opioid epidemic
The action of PBMs, combined…
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MCRA Supports Onkos Surgical with First FDA De Novo Approval for Antibacterial Coating for Implants
WASHINGTON, June 20, 2024 /PRNewswire/ — MCRA, the…
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Providence Medical Technology, Inc. Announces FDA Clearance of CORUS™ Navigation Access System for Use with Medtronic’s StealthStation™ Surgical Navigation in Posterior Spinal Fusion
PLEASANTON, Calif., June 13, 2024 /PRNewswire/ — Providence…
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Spinal Simplicity Announces FDA Clearance of Its Wolff’s Law Anterior Cervical Plate System
Spinal Simplicity announces FDA clearance…
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VUZE Medical Announces U.S. FDA 510(K) Clearance for Second-Generation Software-Based 3D Guidance System for Spine Surgery
VUZE 2.0 provides much-extended interoperability…
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Innovasis Reaches Settlement with Government After Voluntary Self-Disclosure
May 28, 2024 – OrthoSpineNews…
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Spineart Receives 510(k) Clearance for SCARLET® AC-Ti Anterior Cervical Cage
GENEVA, May 28, 2024 /PRNewswire/ — Spineart,…
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FX Shoulder Solutions, Inc. Receives FDA 510k Clearance for Full-Wedge Augmented Glenoid Baseplates
ADDISON, Texas , May 16, 2024 /PRNewswire/ —…
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Orthofix Announces FDA 510(k) Clearance for the Rodeo Telescopic Nail
LEWISVILLE, Texas, May 9, 2024–(BUSINESS…
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OrthoXel Receives FDA 510(k) Clearance for their Vertex Hip Fracture Nail (HFN)
OrthoXel is delighted to announce…
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Biogennix Receives FDA Clearance for Expanded Use of Agilon Moldable and Morpheus Moldable Products
Agilon Moldable Morpheus Moldable IRVINE,…
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