FDA
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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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Regulatory
Simplify Medical Receives FDA Approval for 1-Level Simplify Disc PMA
SUNNYVALE, Calif., Sept. 21, 2020 (GLOBE NEWSWIRE) — Simplify Medical, a privately-held company focused on cervical spinal disc arthroplasty and…
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Regulatory
Spineology® Announces FDA De Novo Grant of Minimally Invasive OptiMesh® Expandable Interbody Fusion System
September 21, 2020 ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving surgery, is excited to announce the FDA grant…
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Recon
NovoPedics Total Meniscus Replacement Device MeniscoFix™ Receives Breakthrough Device Designation from the U.S. Food and Drug Administration
PRINCETON, N.J. (PRWEB) SEPTEMBER 14, 2020 The U.S. Food and Drug Administration’s (FDA) Breakthrough Device Program is intended to expedite the…
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Neuro
Mainstay Medical Announces U.S. FDA Approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain
June 22, 2020 DUBLIN–(BUSINESS WIRE)–Mainstay Medical Holdings plc (“Mainstay” or the “Company”) today announced that the U.S. Food and Drug…
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COVID-19
HHS says vaccine likely by January as it supports speedier development and distribution
June 16, 2020 / Jeff Lagasse, Associate Editor One of the top concerns around the COVID-19 coronavirus is knowing when a…
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COVID-19
FDA Reversal on COVID-19 Mask Decontamination Follows MNA Opposition, Demonstrates Urgent Need for Implementation of Frontline Nurse and Healthcare Professional Guidance
CANTON, Mass., June 8, 2020 /PRNewswire/ — The U.S. Food & Drug Administration (FDA) reversed its position on the use of N95 masks that…
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COVID-19
Association of American Physicians & Surgeons (AAPS) Sues the FDA to End Its Arbitrary Restrictions on Hydroxychloroquine
TUCSON, Ariz., June 2, 2020 /PRNewswire/ — Today the Association of American Physicians & Surgeons (AAPS) filed a lawsuit, AAPS v. FDA, against the…
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COVID-19
FDA Authorizes Quest Diagnostics COVID-19 Nasal Specimen Self-Collection Kit for Emergency Use
SECAUCUS, N.J., May 28, 2020 /PRNewswire/ — Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today announced that it has received…
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Regulatory
Centinel Spine Announces FDA Approval for the Manufacturing Transfer of prodisc® Technology
NEW YORK, May 27, 2020 /PRNewswire/ — Centinel Spine®, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced FDA…
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