Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the first implant system marketed in the U.S. for …
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WASHINGTON, D.C. — The U.S. Food and Drug Administration has granted marketing authorization—under the De Novo premarket review pathway—for an anterior cruciate ligament (ACL) implant, intended to serve as an …
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WEST CHESTER, PA — Centinel Spine, LLC, the largest privately-held spine company focused on anterior column reconstruction, recently announced that it has successfully surpassed 3,500 implantations with its novel FLX™ technology …
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The U.S. Food and Drug Administration issued the final guidance, “Breast Implants – Certain Labeling Recommendations to Improve Patient Communication,” as part of the agency’s effort to help improve the …
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The U.S. Food and Drug Administration is providing an update on adverse events reported to the Agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and …
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WAYNE, PA — Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, this week announced it received U.S. Food and Drug Administration (FDA) approval for …
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