FDA
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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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COVID-19
Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests
SILVER SPRING, Md., May 21, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration posted a list of antibody tests that are being removed…
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COVID-19
COVID-19 Testing in Orthopedics and Spine Clinical Settings—The Unknown Category
As COVID-19 infection rates begin to slow, elective surgery is ramping up and facilities are screening patients for COVID-19. However,…
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COVID-19
FDA probes Abbott’s rapid coronavirus test accuracy issues
May 15, 2020 / Associated Press WASHINGTON – Federal health officials are alerting doctors to a potential accuracy problem with a…
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COVID-19
Moderna’s COVID-19 Vaccine Moves to Phase 2 Testing, and Gets Fast-Track Approval From the U.S. Government
May 12, 2020 / BY ALICE PARK On May 12, Moderna Therapeutics, based in Cambridge, Mass., received fast-track approval from the U.S. Food…
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COVID-19
Drug trio shortens duration and alleviates coronavirus symptoms, study says
May 11, 2020 / By Chris Ciaccia | Fox News Though there is no known scientific cure for COVID-19 yet, a three-drug combination appears…
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COVID-19
Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens
SILVER SPRING, Md., May 8, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration authorized the first diagnostic test with the option…
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COVID-19
COVID-19 Antibody Test Now Directly Available Through LabCorp.com
May 05, 2020 BURLINGTON, N.C.–(BUSINESS WIRE)–LabCorp (NYSE: LH), a leading global life sciences company that is deeply integrated in guiding…
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