Synapse Biomedical, Inc. announced today that the FDA has granted premarket approval (PMA) of the NeuRx^® Diaphragm Pacing System (NeuRx DPS^®) for use in patients with spinal cord injuries who rely on mechanical ventilation.

PMA is the most stringent type of device marketing application required by FDA. More hospitals are expected to begin implementing the NeuRx DPS^® now that they no longer have to undergo the lengthy internal review and approval process required under the previous humanitarian device exemption.

"This is a very big deal for our community," said Jen French, executive director of the North American Spinal Cord Injury Consortium, an advocacy group. "It will improve access and affordability for people living with spinal cord injuries and give them the chance to live life without the restrictions imposed by a ventilator."