FDA
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Regulatory
FDA Grants Breakthrough Device Designation to ORTHOSON’s Bio-Structural Gel
This designation assures enhanced FDA cooperation and priority regulatory review of the company’s novel medical solution for back pain due…
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Biologics
MCRA Announces the Hiring of Former FDA Leadership to Advance its Regenerative Medicine Expertise
WASHINGTON, Nov. 15, 2023 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics focused clinical research organization (CRO) and advisory firm…
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Regulatory
ZKR Orthopedics announces FDA Breakthrough Device designation for the LIFT Implant Technology
KENTFIELD, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) — ZKR Orthopedics, Inc., a clinical stage medical device company, today announced that…
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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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Regulatory
FDA Grants Second Breakthrough Device Designation for Carlsmed Technology
CARLSBAD, Calif., September 20, 2023 — (BUSINESS WIRE)– Carlsmed announced today that the FDA granted Breakthrough Device designation for its…
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Regulatory
DirectSync Surgical receives Breakthrough Device Designation from FDA for its Patient-Powered Smart Implants
LAWRENCE, Kan., May 02, 2023 (GLOBE NEWSWIRE) — DirectSync Surgical, a medical device company dedicated to improving the lives of patients…
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Extremities
Pacira Announces FDA Acceptance of sNDA for Exparel Nerve Blocks to Produce Regional Analgesia in Lower Extremity Procedures
TAMPA, Fla., March 29, 2023 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to…
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