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MCRA CRO Assists Simplify Medical, Recently Acquired by NuVasive, on FDA-Approval for Two Level use of its Cervical Disc


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WASHINGTON, May 12, 2021 /PRNewswire/  MCRA, LLC, the leading privately held medical device and biologics advisory firm and Clinical Research Organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance, and Medical Device Cybersecurity, is pleased to announce its role in the successful management and execution of Simplify Medical s two clinical studies and approvals by the U.S. Food and Drug Administration (FDA) for the Simplify Cervical Artificial Disc (Simplify Disc) to be used at one-level and two contiguous levels in the cervical spine.
Abigail Allen, MCRA s Vice President of Clinical Affairs, said, MCRA is honored to have supported Simplify Medical with the approval of their two-level disc just six months after the one-level approval. It has been a true testament to the teamwork and collaboration between the two companies, and all of our sites ....

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NuVasive's Simplify Disc Receives FDA Approval for Two-Level Cervical Total Disc Replacement


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SAN DIEGO, April 6, 2021 /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 Artificial Disc (Simplify Disc) received approval from the U.S. Food and Drug Administration (FDA) for two-level cervical total disc replacement (cTDR).
This approval is an incredible achievement for the Simplify Disc and further broadens the growth opportunities for the NuVasive C360 portfolio, said Massimo Calafiore, executive vice president, Global Business Units at NuVasive. There is immense surgeon excitement for this latest edition to our cervical offering, and the expanded two-level indication provides greater opportunities to bring the most clinically effective technology in the cTDR market to more patients. ....

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NuVasive Announces Fourth Quarter and Full Year 2020 Financial Results


NuVasive Announces Fourth Quarter and Full Year 2020 Financial Results
Acquires Simplify Medical and the most clinically effective technology in the cervical total disc replacement (cTDR) procedure segment
Submits 510(k) clearance for Pulse platform and reiterates summer 2021 launch
Continued to increase R&D investments in 2020 to advance Company s innovation roadmap
Delivered strong Q4 2020 international growth
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SAN DIEGO, Feb. 25, 2021 /PRNewswire/ NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced financial results for the quarter and full year ended Dec. 31, 2020. ....

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