Synchron’s thought-to-text tech starts clinical trial

April 9, 2019 By Nancy Crotti Leave a Comment

Synchron said it has begun the first clinical trial for its neural interface technology designed to restore communication to people with severe paralysis. The trial will measure the safety of the company’s “thought-to-text” technology by assessing its Stentrode implant in combination with BrainOS software and the stability of high-fidelity signals from the brain to external communications […]

FDA, DoD formalize medical product development deal

November 5, 2018 By Fink Densford Leave a Comment

The FDA said last Friday that it and the U.S. Department of Defense’s Office of Health Affairs inked a Memorandum of Understanding to support medical product development intended to support military personnel. The deal creates a framework through which the FDA and DOD can implement “enhanced engagements” that were part of a law passed by […]

FDA to speed up review of medical products for U.S. military

November 2, 2018 By Chris Newmarker Leave a Comment

The U.S. FDA today announced a memorandum of understanding with the Department of Defense to accelerate regulatory assessment of medical products for military personnel. Congress last year passed a law to expedite regulatory review of products to diagnose, treat or prevent serious diseases or conditions facing U.S. military personnel. The memorandum establishes a framework to implement […]

BrainScope lands $4.5M to add vision assessment to its technology

September 4, 2018 By Nancy Crotti Leave a Comment

The U.S. Department of Defense has awarded BrainScope a $4.5 million research contract to create and integrate ocular capabilities into its handheld, multi-parameter mild traumatic brain injury (mTBI) and concussion products. The Bethesda, Md.-based company’s initial product, BrainScope One, is the first FDA-cleared medical device that can assess the full spectrum of brain injury – from concussions (functional […]

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