Latest medtech regulatory news

Algorithm-powered bionic garment

The lightweight leg-worn Cionic Neural Sleeve was granted U.S. Food and Drug Administration (FDA) clearance for functional electrical stimulation. The device will help people with mobility issues due to multiple sclerosis (MS), stroke, cerebral palsy (CP), and other neurological conditions.

Using advanced algorithms, the system reads the signal sent from the brain to the muscles and can predict a person’s movement 1/10th of a second before their foot lifts off the ground. The Neural Sleeve uses a dense array of sensors to measure how the body is positioned and how individual muscles fire during movement, predicts intended movement by measuring the electrical signal from the brain, and then algorithms analyze this data in real time to determine optimal muscle activation patterns.

ION screw stand-alone spine fixation implant

The U.S. Food and Drug Administration (FDA) has given clearance for the ION screw, a stand-alone spine fixation implant that can be used to treat a variety of pathologies throughout the spine from C2-S1. The smallest posterior fixation implant cleared for spine surgery – smaller than the size of a dime – it can be placed through a tiny incision with minimal tissue disruption.

ION can be used in a variety of open or minimally invasive surgery (MIS). The ION facet screw system instruments were designed to minimize tissue trauma and incision size while delivering the ION implants to the surgical location. The ION has zero profile above the bone which may prevent soft tissue contact and the potential for irritation.