The agency’s move is a win for early screening of a rare genetic disorder, which leads to progressive muscle deterioration.
The electrical nerve stimulator is intended to reduce functional abdominal pain in patients 11–18 years old.
The non-invasive trigeminal nerve stimulation system is intended for patients seven to 12 years old.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
When applicable, the process provides novel products with a speedier route to market.
If all goes as planned, patients who suffer from life threatening or irreversible debilitating conditions will have faster access to new technologies.