FDA grants breakthrough device designation for Parkinson’s treatment platform

The FDA has granted breakthrough device designation to a Spanish health-tech company for its Intelligent Network Modulation System as an adjunctive therapy for treating Parkinson’s disease.

According to a release from Inbrain Neuroelectronics, the therapeutic system includes graphene, a two-dimensional material made of a lattice of carbon atoms, one atom thick. The material’s combination of electrical and mechanical properties fuels a neural platform technology, which utilizes machine learning software that decodes therapy-specific biomarkers to deliver sharply adaptive neuroelectronic therapy that restores and balances pathological neural networks, the company said.

Breakthrough designation expedites the development and FDA review of new devices with the potential to more effectively treat or diagnose life-threatening or irreversibly debilitating conditions.

“Breakthrough device designation from the FDA signifies the potential of the Inbrain neural platform to further improve the lives of patients with Parkinson’s disease,” Dan Gnansia, head of clinical affairs at Inbrain Neuroelectronics, said in the release. “We look forward to working with the agency to help bring this important advance into clinical practice.”