FDA
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Regulatory
Empirical Spine Receives FDA Breakthrough Device Designation for the LimiFlex Device Targeting Degenerative Spondylolisthesis
SAN CARLOS – 31 March 2021 – Empirical Spine, Inc., a company developing advanced solutions for the surgical treatment of spinal…
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COVID-19
FDA says to limit mask decontamination to 4 cycles
January 22, 2021 By Nancy Crotti Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations…
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Biologics
Organogenesis ReNu® Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation For Osteoarthritis of the Knee
FDA Determines ReNu Preliminary Clinical Evidence Indicates Potential to Address Unmet Medical Needs for the Management of Symptoms Associated with…
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Recon
FDA Authorizes Marketing of New Implant to Repair a Torn ACL
SILVER SPRING, Md., Dec. 16, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration granted marketing authorization—under the De Novo premarket review…
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Biologics
Bioventus Receives Authorization to Proceed Under Investigational New Drug Application for Clinical Trial of Placental Tissue Particulate (PTP-001) for the Treatment of Knee OA
November 18, 2020 DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a leader in Solutions For Innovative Healing, received authorization to proceed under its investigational…
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Spine
Simplify Medical Completes PMA Submission for 2-Level Simplify Disc IDE Study
Builds on recent 1-Level PMA Approval SUNNYVALE, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) — Simplify Medical, Inc., maker of the…
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Regulatory
CartiHeal Receives FDA “Breakthrough Device Designation” for the novel Agili-C Implant
KFAR SABA, Israel, Oct. 12, 2020 /PRNewswire/ — CartiHeal, developer of Agili-C™, a proprietary implant for the treatment of cartilage lesions in arthritic…
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Neuro
MCRA Hires Former Leader of FDA Breakthrough Device Program & Neurology Division Manager
WASHINGTON, Oct. 8, 2020 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating…
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Regulatory
MCRA CRO Assists Simplify Medical, Inc. on the Fastest Spine PMA Ever Approved by the FDA
WASHINGTON, Oct. 1, 2020 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics advisory firm and Clinical Research Organization (CRO) integrating U.S.…
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Financial
HHS to allow for the importation of certain drugs from Canada and other countries
September 25, 2020 / Jeff Lagasse, Associate Editor The Department of Health and Human Services on Friday announced that the Trump Administration will…
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