Back to news articles
FDA grants Intelligent Implants breakthrough nod for orthopedics medtech
Hannah DeTavis
The External Control and Power module (ECaP)
The External Control and Power module (ECaP) is a cloud-connected medical wearable that wirelessly powers and communicates with a smart bone implant. Source: Intelligent Implants

Medical device company Intelligent Implants recently announced that the U.S. Food and Drug Administration (FDA) granted its SmartFuse system a Breakthrough Device Designation. The FDA grants this designation to medical devices that offer more effective treatment or diagnosis of debilitating or life-threatening conditions or diseases. The goal of this designation is to help device makers develop, assess, and review these products more quickly while maintaining standards for pre-market approval.

Intelligent Implants’ SmartFuse technology is a wireless orthopedics platform that can remotely stimulate, control, and monitor bone growth. With these features, the SmartFuse system can speed up bone growth and allow providers to remotely monitor patients to aid in real-time decision-making. The company plans to first use the SmartFuse system in lumbar spinal fusions.

In the press announcement on the FDA designation, Intelligent Implants’ CEO remarked: “We are pleased the FDA has granted Breakthrough Device designation for SmartFuse, a next-generation technology platform for orthopedics. It underscores the urgent need for more effective treatments for patients suffering with degenerative disc disease. We look forward to working closely with the FDA through future clinical trials and review processes for SmartFuse. We expect to benefit from additional FDA input during pre-market development as well during the submission process and through an expedited review once the submission is filed. Our goal is to bring this important new technology to a patient population with a significant unmet medical need.”