guidance
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Regulatory
Medtronic Strengthens Leadership in Navigated, Robotic Spine Surgery with FDA Clearance of Midas Rex™ Drills and Navigated Disc Prep and Interbodies for U.S. with Mazor™ Robotic Guidance System
DUBLIN, Dec. 16, 2020 /PRNewswire/ — Medtronic plc (NYSE: MDT) announced that the U.S. Food and Drug Administration (FDA) has cleared the use of…
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COVID-19
Orthopaedic Trauma During COVID-19: Safety for All
by Elizabeth Hofheinz, M.P.H., M.Ed. In these tumultuous times, some orthopedic researchers are training their efforts on bringing a bit…
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Hospitals
Dr. James Lynch is the First US Private Practice Surgeon to Use Augmented Reality Spine Surgical Guidance at a Community Hospital
RENO, Nev., July 1, 2020 /PRNewswire/ — Spine Nevada Minimally Invasive Spine Institute announced that Dr. James Lynch, a board-certified and fellowship-trained neurological…
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Spine
First Augmented Reality Spine Surgery Using FDA-Cleared Augmedics xvision™ Spine System Completed in U.S.
CHICAGO, June 11, 2020 – Augmedics, a pioneer in augmented reality surgical image guidance, has announced its groundbreaking xvision Spine…
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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
White House shelves detailed CDC guide to reopening country
May 7, 2020 / Associated Press A document created by the nation’s top disease investigators with step-by-step advice to local…
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Regulatory
Augmedics Announces FDA 510K Clearance and U.S. Launch of xvision™, the First Augmented Reality Guidance System for Surgery
CHICAGO,12/23/2019– Augmedics, a pioneer in augmented reality surgical image guidance, has announced U.S. Food and Drug Administration (FDA) 510(k) clearance…
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Hospitals
MiMedx Comments On FDA Decision Not To Finalize HCT/P Guidance Documents This Year
MARIETTA, Ga., Feb. 3, 2017 /PRNewswire/ — MiMedx Group, Inc. MDXG 2.31%, the leading regenerative medicine company utilizing human amniotic…
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Hospitals
7D Surgical Receives FDA 510(K) and Health Canada MDL Clearance for Its Breakthrough Image Guidance System for Spine Surgery
TORONTO, Jan. 23, 2017 /PRNewswire/ — 7D Surgical announced today that it has received both 510(k) clearance from the U.S. Food and…
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Hospitals
Use Error Takes a Hit in New MDR Guidance
Posted in Regulatory and Compliance by MDDI staff on November 21, 2016 The FDA has released a final guidance on Medical…
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Financial
First Choice Healthcare Solutions Issues Formal Financial Guidance for 2017 Full Year Revenues and Adjusted EBITDA Margin
MELBOURNE, FL–(Marketwired – Nov 22, 2016) – First Choice Healthcare Solutions, Inc.(OTCQB: FCHS) (“FCHS,” “First Choice” or the “Company”), one…
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Spine
Spinal Elements® and Mighty Oak Medical Announce Marketing Collaboration for FIREFLY® Patient-Matched, 3D Printed Spine Surgery Solutions
October 26, 2016 CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a spine technology company, announced that they will be working with Mighty Oak…
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Hospitals
Nation’s Leading Developer of Advanced Wound Care Technologies Urges FDA to Finalize Regulatory Guidance to Ensure Safety and Efficacy of Section 361 HCT/Ps
CANTON, Mass., Sept. 12, 2016 /PRNewswire/ — Organogenesis Inc., a global leader in FDA-approved and FDA-cleared advanced wound care innovation and technologies, today…
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Hospitals
FDA Issues Draft Guidance on Additive Manufactured Devices
By: Carolyn LaWell Page 1 of 2 FDA recently published draft guidance on technical considerations for additive manufactured devices…
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Hospitals
FDA Guidance on 3D Printing a ‘First Step’
by Joyce Frieden, News Editor, MedPage Today WASHINGTON — The FDA’s recently issued draft guidance on 3D-printed medical devices does…
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