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Celltrion’s Yuflyma receives US FDA approval for multiple conditions

Pharmaceutical Technology

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. It will be offered to patients in prefilled syringe and autoinjector administration options.

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Activ Surgical Secures CE Mark Approval for ActivSight™ Intelligent Light

Legacy MEDSearch

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

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Vivasure Medical Announces FDA IDE Approval to Initiate U.S. Pivotal Study

Legacy MEDSearch

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. and Europe.

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Lumicell Submits New Drug Application for LUMISIGHT™ Optical Imaging Agent to U.S. FDA for Intraoperative Breast Cancer Detection and Removal

Legacy MEDSearch

a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). Lumicell, Inc., Are you hiring?

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MicroPort Navibot Receives 510(K) Clearance for its SkyWalker™ Robot-Assisted Platform for Orthopedic Applications

Legacy MEDSearch

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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Zeta Surgical’s Mixed Reality Navigation System Receives FDA Clearance

Legacy MEDSearch

Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system. ” About Zeta Surgical Zeta Surgical is a digital surgery company focused on improving the accuracy, safety, and accessibility of image guided procedures.

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UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Legacy MEDSearch

This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration). Food and Drug Administration (FDA) for UroActive. Aurélien Beaugerie and Dr. Christophe Vaessen.