TGA opened a consultation for regulation of assistive technologies, a key element of which is to make determinations about the regulatory status of some of these products. While the agency makes clear that some items that are currently unregulated may soon be subject to regulation, one of the more innocuous-seeming articles that may fall under regulation is the common and seemingly innocuous wig.
The first patenting from Los Angeles-based Ecate LLC sees the company’s founder, Allesandro Maggi, describe a bi-directional, closed-loop spinal cord machine interface that can bridge the gap in communication between the brain and the body in paralyzed patients.
In what represents its first patenting, Pittsburgh-based Reach Neuro Inc. is seeking protection for methods, sensors, and systems for detecting movement of a spine and stimulating specific regions of the spinal cord in response to the movement.
Boston Scientific Corp. notched another win with the U.S. FDA approval of its spinal cord stimulator (SCS), Wavewriter, for treatment of non-surgical back pain just a week after receiving the agency’s nod for its Farapulse pulsed field ablation system. The new indication comes four months after expansion of approved uses for Wavewriter to include painful diabetic peripheral neuropathy.
A team of inventors from Artarmon, Australia-headquartered Saluda Medical Pty Ltd. including founder and former CEO, John Parker, applied for patent protection for enhancements to the neurostimulation monitoring capabilities of Evoke.
Abbott Laboratories received U.S. FDA approval for an expanded indication for its spinal cord stimulator (SCS) devices to include treatment of chronic back pain for individuals who have not had or are ineligible for back surgery. The FDA based its decision on the positive results from the DISTINCT study which showed that 85.2% of patients implanted with the SCS devices achieved significant reduction in back pain compared to 7.1% of those who received conservative medical management.
The U.S. FDA approved the Proclaim XR spinal cord stimulation system by Abbott Laboratories for painful diabetic peripheral neuropathy (DPN). The system offers an alternative to patients for whom oral medications do not provide sufficient relief. About half of individuals with diabetes will eventually develop peripheral neuropathy which primarily damages the nerves running down the legs to the feet.
Seven new U.S. medtechs are poised to make a splash in the diagnosis and treatment of nervous system disorders thanks to funding under a new program within the National Institutes of Health (NIH) Blueprint for Neuroscience Research called Blueprint Medtech.
Onward Medical NV reported clinical outcomes for the first 10 patients given therapy to regulate blood pressure using its implantable ARC technology. This pulse generator produced an immediate improvement in blood pressure regulation in all study participants.
