FDA
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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
MCRA Assists BONESUPPORT AB with the First Ever Combination Product DeNovo Decision Granted by the U.S. FDA
CERAMENT G is the first combination product which has successfully navigated the DeNovo process.To date, MCRA has supported 5 of…
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Recon
Exactech Announces FDA Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing System
May 17, 2022 GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement…
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Spine
Spine BioPharma Initiating U.S. Phase 3 Clinical Study
SB-01 For Injection Offers New Potential Treatment for Patients Sufferingfrom Chronic Low Back Pain. New York, NY., May 11, 2022…
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Regulatory
FDA Grants PMA for the AccelStim Bone Growth Stimulation Device — Expanding Orthofix’s Portfolio of Market-Leading Bone Healing Therapy Solutions
May 4, 2022 LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus,…
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Regulatory
AxioMed Announces Progress with Completing Module I-III Lumbar FDA Submission of The First Lumbar Viscoelastic Disc Replacement to Complete a US IDE Clinical Study
AxioMed presses forward on its FDA submission of documents needed to complete the last Module III of its FDA application…
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Regulatory
FDA approves CartiHeal’s Implant for the Treatment of Cartilage and Osteochondral Defects
Approval is based on results of a multicenter, randomized, open-labeled and controlled IDE clinical study that demonstrated the superiority of…
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Biologics
Cerapedics Completes Enrollment of Pivotal U.S. FDA IDE Study for its P-15L Bone Graft
The ASPIRE study is intended to evaluate the use of P-15L Bone Graft in transforaminal lumbar interbody fusion surgery in…
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Spine
AxioMed LLC Files PMA Module II of III targeting 2022 FDA Approval of The First and Only Viscoelastic Lumbar Disc Replacement to Complete an IDE Clinical Study
AxioMed takes another historic step towards achieving FDA approval of its lumbar viscoelastic total disc replacement after submitting PMA Module…
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Recon
Hip Innovation Technology Receives FDA Investigational Device Exemption (IDE) Approval to Initiate Landmark Study of its Reverse Hip Replacement System
HIT’s Reverse Hip Replacement System may Revolutionize Total Hip Replacement Surgery BOCA RATON, Fla., Jan. 18, 2022 /PRNewswire/ — Hip Innovation Technology, LLC…
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Regulatory
FDA authorizes COVID-19 pills from Pfizer and Merck
The treatment has been cleared for anyone 12 years old and older who is at high risk for severe COVID-19,…
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Extremities
Paragon 28’s Patient Specific Titanium Talus Spacer Has Been Approved by the U.S. Food and Drug Administration
December 13, 2021 ENGLEWOOD, Colo.–(BUSINESS WIRE)–Paragon 28, Inc. (NYSE: FNA) announced today that it has received a supplemental approval order from…
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Regulatory
AxioMed LLC Reports Landmark Filing of Initial PMA Module to FDA as the First Viscoelastic Lumbar Artificial Disc Replacement to Complete an IDE Clinical Study
AxioMed seeks to get FDA clearance in 2022 to press its leadership position as the only viscoelastic total disc replacement…
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Regulatory
Amber Implants VCFix® spinal system receives US FDA Breakthrough designation
HAGUE, Netherlands, Oct. 5, 2021 /PRNewswire/ — Amber Implants, an innovative medical technology company developing next generation spinal implants for spinal injuries, today…
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COVID-19
Merck says new COVID-19 medication cuts the risk of hospitalization and death
Merck plans to submit an application for Emergency Use Authorization to the FDA soon based on these findings. October 4,…
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