FDA Approval
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Biologics
Cerapedics’ i-FACTOR P-15 Peptide Enhanced Bone Graft, a Trusted Choice in Bone Graft Solutions, Now Approved for Expanded Indications for Use
Approval underscores Cerapedics’ commitment to investing in evidence that brings scientific rigor to bone grafting for spinal fusion. WESTMINSTER, Colo., Sept.…
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Spine
DiscGenics Announces US FDA Approval to Proceed with Phase III Clinical Evaluation of Allogeneic, Injectable Disc Progenitor Cell Therapy for Symptomatic Lumbar Degenerative Disc Disease
Receives FDA acceptance on Phase III clinical protocols for parallel pivotal and confirmatory trials Achieves alignment with FDA on Chemistry,…
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Regulatory
Medtronic receives FDA approval for Inceptiv™ closed-loop spinal cord stimulator
Closed-loop sensing capability instantly and automatically adjusts therapy while treating chronic pain DUBLIN, April 26, 2024 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global…
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Neuro
Mainstay Medical Announces Receipt of FDA Approval for MRI Labeling on ReActiv8® Restorative Neurostimulation System™
U.S. patients implanted with ReActiv8 now eligible for full-body MRI scans DUBLIN, February 12, 2024–(BUSINESS WIRE)–Mainstay Medical Holdings plc today…
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Spine
ZimVie Announces FDA Approval to Launch Mobi-C® Hybrid Study
Decision clears the way for enrollment of U.S. patients in a groundbreaking clinical study of cervical arthroplasty adjacent to fusion…
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Extremities
Paragon 28®, Inc. Receives FDA Approval for IDE Feasibility Study of Its SMART Total Talus™ System for use in Conjunction with the APEX 3D™ Total Ankle Replacement System
Paragon 28’s first in the world 3D-printed Patient Specific Talus Spacer. Use in treatment of avascular necrosis (AVN). FDA approval:…
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Regulatory
ZimVie Announces FDA Approval for New Mobi-C® Implant
Smaller height implants in all Mobi-C footprints to address patient anatomy WESTMINSTER, Colo., Aug. 10, 2023 (GLOBE NEWSWIRE) — ZimVie…
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Spine
Globus Medical Announces FDA Approval for its Non-Fusion Scoliosis Correction System, the Latest Advancement for Young Patients with Idiopathic Scoliosis
REFLECT™ is approved through the FDA’s Humanitarian Device Exemption pathway AUDUBON, Pa., May 15, 2023 (GLOBE NEWSWIRE) — Globus Medical,…
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Regulatory
Bioretec is the first in the world to receive FDA approval for a bioresorbable metal product
TAMPERE, Finland, March 30, 2023 /PRNewswire/ — Bioretec Ltd, a pioneer in bioresorbable[1] orthopedic implants, has today announced receiving the market authorization of…
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Recon
LimaCorporate Announces FDA Approval for new “PRIMA” Shoulder Platform Including Short Stem and TT Glenoid
Udine, Italy, Oct. 7, 2022 /PRNewswire/ — LimaCorporate proudly announces the FDA approval of a new shoulder platform focused on versatility and Operating…
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Biologics
Lipogems® Receives IDE Approval From The U.S. FDA To Begin A Pivotal Clinical Study On The Safety And Effectiveness Of The Lipogems System For The Treatment of Knee Osteoarthritis
ATLANTA , June 10, 2022 /PRNewswire/ — Lipogems is pleased to announce the unconditional approval by the U.S. Food and Drug Administration (FDA) to…
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COVID-19
FDA Approves First COVID-19 Vaccine
Approval Signifies Key Achievement for Public Health August 23, 2021 Today, the U.S. Food and Drug Administration approved the first…
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Regulatory
NuVasive’s Simplify Disc Receives FDA Approval for Two-Level Cervical Total Disc Replacement
Simplify® Cervical Artificial Disc achieved the highest overall clinical success rate at both one- and two-levels compared to any other…
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Extremities
Nation’s Top Orthopedic Hospital Launches the First FDA Approved Digital Pathology Platform
NEW YORK, Feb. 9, 2021 /PRNewswire/ –Hospital for Special Surgery (HSS), the world’s leading academic medical center specializing in orthopedics, rheumatology, and related…
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Regulatory
Simplify Medical Announces First Implantation of its Cervical Artificial Disc in the U.S. Following 1-Level Approval from the FDA
SUNNYVALE, Calif., Dec. 16, 2020 (GLOBE NEWSWIRE) — Simplify Medical, Inc., a privately-held company focused on cervical spinal disc arthroplasty and…
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