ide
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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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Hospitals
CartiHeal Announces FDA IDE Approval of Its Agili-C Implant for the Treatment of Joint Surface Lesions
KFAR SABA, Israel, Dec. 20, 2016 /PRNewswire/ — CartiHeal (2009) Ltd., developer of a cell-free, off-the-shelf implant for use in…
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Hospitals
Regentis Receives IDE Approval for Pivotal GelrinC Clinical Trial
Princeton, NJ and Or Akiva, Israel, September 26 — Regentis Biomaterials, a developer of hydrogels for tissue regeneration, announced it…
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Hospitals
BONESUPPORT™ Receives FDA Approval to Initiate IDE Clinical Study with CERAMENT™G
Lund, Sweden, 9 August – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone…
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Hospitals
FDA: IDE review times reduced by nearly a year
By Fink Densford The FDA released a report detailing improvements in clearing medical devices, stating it reduced investigational device exemption…
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Recon
OrthoSpace Enrolls First Patients in US IDE Study
CAESAREA, Israel, July 6, 2015 /PRNewswire/ — OrthoSpace Ltd. (“OrthoSpace” or “Company”) announced today the enrollment of the first three patients in its…
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Extremities
Anika Therapeutics Files Investigational Device Exemption to Initiate Phase III Study to Expand Indication of MONOVISC® to Treat Pain Caused by Osteoarthritis of the Hip
BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc., (NASDAQ: ANIK), a leader in products for tissue protection, healing, and repair based on hyaluronic…
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