Ćorić

Premia Spine Completes FDA Site Inspections With No FDA Observations

Retrieved on: 
Thursday, April 13, 2023
Biotechnology, Surgery, General Health, Health, FDA, Medical Devices, Health Technology, Clinical Trials, Spine, Clinical trial, Index, Control, Back pain, Ćorić, Motion, PMA, Journal, Patient, Decompression, Cleveland, IDE, Spinal stenosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Treatment, Food, Lumbar spinal stenosis, Pharmaceutical industry, DRS, Spondylolisthesis

The inspections at two company facilities and two clinical trial sites in the U.S. resulted in no FDA Form 483s for objectionable observations.

Key Points: 
  • The inspections at two company facilities and two clinical trial sites in the U.S. resulted in no FDA Form 483s for objectionable observations.
  • “While a completely clean site inspection is what everyone strives for, it is a major accomplishment to receive no 483s across four separate sites,” said Ron Sacher, CEO, Premia Spine.
  • Coric, Steinmetz, their staff, and the other 35 clinical sites who diligently performed the IDE study to the highest standards,” responded Jeff Withrow, vice president, Clinical and Reimbursement, Premia Spine.
  • TOPS won Breakthrough Device Designation from the FDA in 2021.

3Spine, Inc. Announces Medical Advisory Board Appointment

Retrieved on: 
Thursday, June 2, 2022
Nunley, IDE, Research, NEL, Spine, Associate, Food, Food and Drug Administration Amendments Act of 2007, International Society, Back pain, Cayman Islands, DRS, Patient, Trial of the century, Medical director, Movement, MAB, American Board of Commissioners for Foreign Missions, Education, LSU, Medical device, Ćorić, MD, Greater Boston

NASSAU, Bahamas, June 2, 2022 /PRNewswire/ -- 3Spine, Inc., a U.S. medical device company developing total joint replacement for the lumbar spine, today announced the appointment of Pierce Nunley, MD, to the company's Medical Advisory Board (MAB).

Key Points: 
  • NASSAU, Bahamas, June 2, 2022 /PRNewswire/ -- 3Spine, Inc., a U.S. medical device company developing total joint replacement for the lumbar spine, today announced the appointment of Pierce Nunley, MD, to the company's Medical Advisory Board (MAB).
  • The MAB appointment was made at the International Society for the Advancement of Spine Surgery (ISASS) meeting in the Bahamas.
  • Dr. Nunley is Director of the Spine Institute of Louisiana in Shreveport, LA, chairman of the American Board of Spine Surgery, and an Associate Professor at LSU.
  • "Pierce is a friend and a real technology leader," said Dr. Scott Hodges, co-founder and Medical Director of 3Spine.

NuVasive Simplify Cervical Disc Two-level Data Published in Journal of Neurosurgery: Spine

Retrieved on: 
Thursday, April 21, 2022
Online, News, Elective surgery, Carolinas Medical Center, ACDF, Ćorić, Disability, PCF, Spine, Software, NASDAQ, Food, Hospital, Patient, SAN, Trial of the century, Surgeon, Conference, Technology, Company, Bureau of Oceans and International Environmental and Scientific Affairs, Journal, International Society, NuVasive, Rate, Safety, IDE, FDA, Industry, Multimedia, NDI, Birth control, Dentistry, Medical device, MD, Neurosurgery

SAN DIEGO, April 21, 2022 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify® Cervical Disc (Simplify Disc) two-level U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study data was recently published in the Journal of Neurosurgery: Spine. The data were utilized in the device's FDA pre-market application for two-level indication approval, which was approved in April 2021.

Key Points: 
  • SAN DIEGO, April 21, 2022 /PRNewswire/ --NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive SimplifyCervical Disc (Simplify Disc) two-levelU.S.
  • Food and Drug Administration(FDA) Investigational Device Exemption (IDE) study data was recently published in the Journal of Neurosurgery: Spine .
  • "This peer-reviewed publication adds to the growing body of clinical evidence in support of the Simplify Disc," saidKyle Malone, vice president of Scientific Affairs atNuVasive.
  • The Simplify Disc is part of the NuVasive C360 portfolio , which offers comprehensive, procedurally integrated solutions for the anterior and posterior cervical spine, including ACDF, cTDR and posterior cervical fusion (PCF) procedures.