ide
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Regulatory
Lipogems Announces Last Patient Enrolled in the U.S. FDA IDE Arise Study for the Treatment of Knee Osteoarthritis
Orthopaedic surgeon, Dr. Cristin Mathew, enrolls a patient in the Lipogems ARISE US FDA IDE Knee OA Study ATLANTA, April 10,…
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Regulatory
Lipogems Announces First Patient Enrolled in the Second U.S. FDA IDE Study for the Treatment of Knee Osteoarthritis
Orthopaedic surgeon, Dr. Yogesh Mittal, enrolls the first patient in the ARISE 2 Study for Knee Osteoarthritis ATLANTA, April 8, 2024 /PRNewswire/…
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Biologics
U.S. FDA Grants Lipogems® Second IDE Approval For A Clinical Trial On The Treatment For Knee OA
ATLANTA, Oct. 4, 2023 /PRNewswire/ — The U. S. Food and Drug Administration (FDA) has awarded Lipogems another Investigational Device Exemption (IDE) study…
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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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Spine
Synergy Spine Solutions Announces First Patient Enrolled in the Synergy Disc® 2-Level IDE Trial
LOUISVILLE, Colo., June 29, 2023 /PRNewswire/ — Synergy Spine Solutions Ltd, an innovative orthopaedic medical device developer focused on artificial cervical disc…
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Spine
Synergy Spine Solutions Completes Enrollment of 1-Level IDE Trial
LOUISVILLE, Colo., June 5, 2023 /PRNewswire/ — Synergy Spine Solutions Ltd, an innovative orthopaedic medical device developer focused on artificial cervical disc…
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Spine
AxioMed LLC Submits Final Module III to the FDA Becoming the First and Only Lumbar Viscoelastic Total Disc Replacement Company to Complete a USA IDE Clinical Trial
On August 8, 2022, AxioMed LLC submitted to the FDA all the required documents for Module III. This is the…
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Spine
3Spine, Inc. Completes First US Surgeries
CHATTANOOGA, Tenn., June 29, 2022 /PRNewswire/ — 3Spine, Inc., a medical device company developing total joint replacement for the lumbar spine, today…
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Spine
3Spine, Inc. Announces IDE Approval
CHATTANOOGA, Tenn., June 22, 2022 /PRNewswire/ — 3Spine, Inc., a medical device company developing total joint replacement for the lumbar spine, today…
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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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Spine
Orthofix M6-C Artificial Cervical Disc IDE Study Data to be Presented at ISASS Demonstrates Continued Statistically Significant Benefits at Five Years
Additionally, analysis of two-year physiological range of motion data from multiple artificial cervical disc IDE studies to be presented showing…
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Spine
Spineart-100 U.S. Patients Treated In The Single Level IDE Clinical Trial Of BAGUERA®C Cervical Disc Prosthesis
LAGUNA HILLS, Calif., April 21, 2022 /PRNewswire/ — Spineart USA Inc. announced today that surgery has been performed on 100 patients in the single-level U.S.…
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Spine
Orthofix M6-C Artificial Cervical Disc IDE Study Three- and Four-Year Data to be Presented at ISASS
May 13, 2021 LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus,…
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Biologics
Cerapedics Announces FDA approval of an IDE supplement
WESTMINSTER, Colo., July 22, 2020 — Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA)…
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Spine
New long-term data on the effect of lumbar total disc replacement on adjacent level degeneration reinforces outcomes from previous studies
CENTER VALLEY, Pa., May 8, 2017 /PRNewswire/ — Aesculap Implant Systems, LLC announced today that Dr. Richard Guyer of the Center…
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