FDA De Novo Approval
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Biologics
MCRA Supports Onkos Surgical with First FDA De Novo Approval for Antibacterial Coating for Implants
WASHINGTON, June 20, 2024 /PRNewswire/ — MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory…
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Regulatory
Onkos Surgical Announces First FDA De Novo Approval of an Antibacterial Coating for Tumor and Revision Orthopaedic Implants
– Bacterial contamination of orthopaedic implants is a growing clinical challenge that burdens the healthcare system and can lead to…
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Regulatory
MCRA Assists Active Life Scientific with Clinical Study Execution and Successful De Novo Decision for the OsteoProbe – A New Tool to Measure Bone Tissue
– MCRA’s CRO and Regulatory Teams assisted Active Life Scientific, Inc. with integrated regulatory and clinical research services to support…
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Recon
Zimmer Biomet and Canary Medical Announce FDA De Novo Classification Grant and Authorization to Market the World’s First and Only Smart Knee Implant
– Persona IQ® Knee Implant Combines ZB’s Proven and Trusted Persona® Knee with Canary Medical’s Proprietary Implantable canturio™ te Tibial…
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Regulatory
Intellirod Spine Receives First-Ever Spine FDA De Novo Approval
April 01, 2019 AKRON, Ohio–(BUSINESS WIRE)–Intellirod Spine, the spinal sensor technology company developing wearable, disposable and implantable wireless sensors for…
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