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Fusion Robotics Receives 510(k) Clearance for Spinal Navigation and Robotics System

Fusion Robotics LLC, a spinal robotics and navigation company has received 510(k) clearance to market its 3D imaging compatible navigation and robotic targeting system for spine surgery in the U.S. market.

ECRI and oneSOURCE Plan Alerts Management Collaboration

ECRI and oneSOURCE Document Management Services have announced a joint collaboration focused on improving medical device safety and responsiveness of health care facilities.

TransEnterix Announces Name Change, Introduces a New Category of Surgery

The name change reflects the company’s broader vision of shaping the future of surgery by integrating computer vision and machine learning with surgical robotics.

Fujifilm Systems Integration Leads AIA-Accredited Course

During this one hour course, participants will learn about the importance of continuing to digitize systems and processes in the OR, the role digitization plays in ensuring that various technologies used during procedures are connected and accessible, and why it’s important to understand this evolution as architects and equipment planners.

Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders

Allergan plc has announced a voluntary worldwide recall of BIOCELL®textured breast implants and tissue expanders. Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA).

BIOCELL®saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available. Effective immediately, healthcare providers should no longer implant new BIOCELL® textured breast implants and tissue expanders and unused products should be returned to Allergan. Allergan will provide additional information to customers about how to return unused products.

Patient safety is a priority for Allergan. Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns.

Importantly, the FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients.

This global recall does not affect Allergan’s NATRELLE® smooth or MICROCELL® breast implants and tissue expanders.

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