FDA Approval
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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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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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Hospitals
Another FDA Approval For Spinal Cord Stimulation
Spinal Cord Stimulation has been around since 1989 as a treatment for chronic pain, and companies that make the devices…
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Financial
Wright Medical delays Augment timeline
By Brad Perriello Wright Medical says it now expects its Augment bone graft to win FDA approval in the 2nd…
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Hospitals
What are the FDA Usability Testing Requirements for Device Approval?
By Thomas Klein In a government-sponsored workshop on usability in 2011, the FDA’s 510(k) team leader regarding human factors presented…
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