FDA Approval
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Recon
LimaCorporate Announces FDA Approval for an Ide Study on Smr Stemless Reverse Shoulder System
UDINE, Italy, Nov. 19, 2020 /PRNewswire/ — LimaCorporate is proud to announce that the U.S. Food and Drug Administration (FDA) has approved the…
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Regulatory
FDA Approves joimax® Intracs®em Electromagnetic Navigation System for Endoscopic Minimally Invasive Spine Surgery
August 6, 2020 IRVINE, Calif.–(BUSINESS WIRE)–joimax®, the German-based market leader in technologies and training methods for full-endoscopic and minimally invasive…
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Biologics
Cerapedics Announces FDA approval of an IDE supplement
WESTMINSTER, Colo., July 22, 2020 — Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA)…
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Regulatory
Orthofix Announces FDA Approval of STIM onTrack 2.1 Mobile App for Bone Growth Stimulators
February 13, 2020 LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal products and therapies,…
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Hospitals
Medtronic Announces FDA Approval of Infuse(TM) Bone Graft in New Spine Surgery Indications Using PEEK Interbody Implants
DUBLIN – April 30, 2018 – Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval of Infuse(TM)…
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Hospitals
InVivo Therapeutics Receives FDA Approval for Pivotal, Randomized, Controlled Trial of the Neuro-Spinal Scaffold™ in Patients with Acute Spinal Cord Injury
March 08, 2018 CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that the company has received supplemental Investigational Device Exemption…
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Hospitals
Medtronic Announces FDA Approval and U.S. Launch of Next Generation Spinal Cord Stimulator for Chronic Pain Management
DUBLIN – September 18, 2017 – Medtronic plc (NYSE:MDT) today announced FDA approval and U.S. launch of the Intellis(TM) platform for…
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Hospitals
Ziptek LLC Receives FDA Approval For ZipE®, the Innovative Knotless Tissue Repair Device
By PR Rocket on April 20, 2017 Ziptek LLC, founded by Sarasota-based orthopedic surgeon Dr. William Bennett M.D., is proud…
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Financial
Sales growth, a completed merger and FDA approval highlight third quarter for Wright Medical
By Michael Sheffield Memphis-based Wright Medical Group saw a 12 percent increase in sales for the third quarter of 2015. The company,…
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Hospitals
Study: Breakthrough med devices slower to market than blockbuster drugs
By Fink Densford Medical device companies producing pioneering medical technology have a much longer, more expensive road to travel to…
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Hospitals
VertiFlex® Inc. Announces FDA PMA Approval for the Superion® Interspinous Spacer VertiFlex
VertiFlex® Inc. a leading innovator of advanced minimally invasive interventions for spinal stenosis announced today that the U.S. Food and Drug…
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Spine
Elmhurst Hospital using new implant to treat spine fractures
By Edward-Elmhurst Healthcare A car accident, a slip on an icy sidewalk, a fall from a ladder – it only…
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Hospitals
FDA clears Nevro spinal stimulation system for pain management
Today the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid…
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Hospitals
St. Jude Medical Receives FDA Approval for the World’s Smallest Upgradeable MR-Conditional Spinal Cord Stimulation System
T. PAUL, Minn., Apr 30, 2015 (BUSINESS WIRE) — St. Jude Medical, Inc. STJ, -0.31%a global medical device company, today announced FDA…
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Biologics
Congress should hold oversight hearings to ensure FDA prioritizes safety for biosimilars
By James Weisman The Food and Drug Administration recently approved the first in a new category of biologic drugs known…
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