Current regulatory news

FDA approval for Inceptiv closed-loop spinal cord stimulator

The U.S. Food and Drug Administration (FDA) has approved Medtronic’s Inceptiv closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. Inceptiv is the first Medtronic SCS device offering a closed-loop feature sensing biological signals along the spinal cord and automatically adjusting stimulation in real time, keeping therapy in harmony with the motions of daily life.

Traditional fixed-output SCS devices deliver constant, mild electrical impulses disrupting pain signals before they reach the brain. As patients go about their daily lives, certain movements such as laughing, bending, or sneezing may result in brief moments of uncomfortable overstimulation. This may lead some patients to turn down their device’s stimulation output, resulting in a suboptimal therapy experience.

By contrast, Inceptiv SCS senses biological signals and consistently maintains the physician’s prescribed stimulation tailored to a patient’s needs. Specialized circuitry and a proprietary algorithm detect evoked compound action potentials (ECAPs), signals generated by the spinal cord in response to electrical stimuli. ECAPs are a direct measure of how much nerve tissue is activated in the spinal cord and can be used to inform real-time adjustments to stimulation. Inceptiv SCS senses the body’s response to stimulation 50x per second and instantly increases or decreases stimulation to maintain prescribed settings as determined by the physician.

https://www.medtronic.com/inceptiv

FDA 510(k) clearance for UltraThineer

Boston Micro Fabrication (BMF) received U.S. Food and Drug Administration (FDA) 510(k) clearance for its UltraThineer material used to create the world’s thinnest cosmetic dental veneer. The 3D-printed veneers use projection micro stereolithography (PµSL), a technology allowing for greater resolution, accuracy, and precision, to custom-manufacture veneers 3x thinner than traditional veneers. Further, UltraThineer requires significantly less preparation for dental professionals, allowing preservation of the patient’s original enamel with a more realistic final appearance.

UltraThineer veneers feature advanced material, a production workflow, and the finishing process to deliver more comfortable and less invasive options in cosmetic dentistry.