Synapse Biomedical gets FDA OK for diaphragm pacing device in ALS
Synapse Biomedical Inc. in Oberlin, Ohio, has received Humanitarian Use Device approval from the Food and Drug Administration for its NeuRx Diaphragm Pacing System in certain ALS patients. The designation is a step toward getting a full-blown Humanitarian Device Exemption (HDE), for which Synapse Biomedical applied on Friday.