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NeuroMed Devices

Oakley, Utah, United States

Ownership: Private
Development stage: Other

Overview

NeuroMed Devices, Inc. is a medical technology company founded by Dr. Leon M. Silverstone that specialized in the development of non-invasive neuromodulation systems. The company's flagship products, ViraCalm™ and OraCalm™, were designed to deliver electrical stimulation to the peripheral nervous system for the management of chronic and acute pain. While the devices received FDA 510(k) clearance for pain relief, the company faced significant regulatory scrutiny for promoting them as treatments for herpes simplex virus (HSV) infections without clinical evidence. This led to a formal warning letter from the FDA and the eventual cessation of the company's commercial activities.

Therapeutic areas: NeurologyInfectious Diseases
Modalities: DeviceNeuromodulation
Industry: Therapeutic Medical Devices

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