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The SmartFuse, Intelligent Implants Ltd.’s new orthopedic implant, has been cleared for use by the Food and Drug Administration (FDA) through FDA device registration. The technology remotely stimulates and controls bone growth and monitors for clinical decisions that can be made instantaneously. The new device is clear for first use in patients who need lumbar spinal fusions.
The new technology aims at providing a more effective way to treat patients who suffer from degenerative disc diseases. Intelligent Implants plans on working closely with the FDA to continuously improve its process, including the use of clinical trials. The device is still in premarket development and will likely rely heavily on FDA input.
CEO of Intelligent Implants, John Zellmer, says of the SmartFuse, “Our goal is to bring this important new technology to a patient population with a significant unmet medical need.” SmartFuse is designed to provide therapeutic benefits and provide data in real-time to support the care physicians bring during therapy.
Intelligent Implants, a privately owned bioelectronics company based in Ireland, pioneers the use of data, engineering, and medicine to bring new devices to healthcare. Their integrated devices bring patient treatment while allowing decision-making for health care professionals. The majority of their products are minimally invasive, using wireless power to provide both comfort and convenience and allow their products to be more mechanically robust. For more information on Intelligent Implants, please visit them online.
UReg – FDA Registration provides services to register and remain compliant with FDA rules and regulations. For any questions about FDA food registration, please visit us online or call 786.461.1114.