Medical Devices



Alzheimer’s Device
The U.S. Food and Drug Administration (FDA) is officially considering the use of the first-ever medical device to treat the symptoms of Alzheimer’s disease.

That’s an exciting prospect, for reasons IEEE Spectrum lays out in a new story about the startup Neuronix: no single drug has yet been approved by the FDA that has been shown to slow the progress of the devastating neurodegenerative disease.

Magnetic Stimulation
A panel from the FDA’s Advisory Committee is meeting today to discuss a device built by the Israeli company. The panel’s task: to investigate if the device provides clinically meaningful benefit and the overall benefit-risk ratio.

The machine, called the NeuroAD, is technically already approved for medical use in Israel, Europe, and Asia, according to IEEE Spectrum. The device manufacturer has been seeking FDA approval since at least early 2016.

The machine uses a technique called “transcranial magnetic stimulation,” a treatment that is more commonly used as a treatment for depression. While the patient is strapped into the device, they do cognitive training exercises consisting of basic memory tests related to language and comprehension, in order to strengthen neural connections in the brain.

“Meaningful Improvement”
Clinical trials of the device show “meaningful improvement” to patients suffering from Alzheimer’s, according to Neuronix CEO Eyal Baror.

“For a tough disease like Alzheimer’s, this is a really important tool,” Baror told IEEE Spectrum. “We’re not attempting to cure Alzheimer’s, unfortunately, but we’re attempting to modify the course of the disease.”

Alvaro Pascual-Leone, a professor of neurology at Harvard Medical School, warned IEEE Spectrum to remain skeptical pending the FDA’s conclusions — but also stressed the importance of Alzheimer’s research.

“This is a devastating disease for the patient, the family, and society as a whole,” he said. “There’s a real need for something that can help.”


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