Synapse Awaits Humanitarian Approval For Diaphragm Pacing System To Treat ALS
This article was originally published in The Gray Sheet
Executive Summary
Synapse Biomedical expects FDA to issue a humanitarian device exemption within weeks allowing its NeuRX diaphragm pacing system to be marketed to treat patients with amytrophic lateral sclerosis.
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Synapse Biomedical will pursue expanded approval of its diaphragm pacing system to facilitate breathing in patients with Lou Gehrig's disease after gaining a humanitarian device exemption June 17 for use by ventilator-dependent spinal cord injury patients, according to the company