U.S. Food and Drug Administration (FDA)
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Regulatory
FDA Grants Theradaptive Breakthrough Medical Device Designation
FREDERICK, Md., Nov. 19, 2021 /PRNewswire/ — Theradaptive, a privately held biopharmaceutical company pioneering a new class of regenerative implants announced that…
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Regulatory
FDA approves first of its kind device to treat pediatric patients with progressive idiopathic scoliosis
SILVER SPRING, Md., Aug. 16, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved the first spinal tether device intended to…
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Regulatory
Medacta Enters U.S. and Australian Sports Medicine Market with Dynamic Lineup of Surgical Solutions
CASTEL SAN PIETRO, 30 July 2019 – Building on 20 years of innovation in joint replacement and spinal surgery, Medacta…
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Regulatory
Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, on agency’s efforts to increase transparency in medical device reporting
SILVER SPRING, Md., June 21, 2019 /PRNewswire/ — In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center…
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