FDA award 510(k) clearance to SpringTMS for Migraine - eNeura

eNeura has received FDA 510(k) clearance for its SpringTMS Migraine treatment device. SpringTMS is the first medical device available to patients in the United States for the acute treatment of pain associated with Migraine Headache with aura. SpringTMS is currently CE Marked in Europe and is available to patients in the United Kingdom for acute treatment of migraine.

SpringTMS provides the same therapy as the Cerena device but offers improved portability. Approval is based on a double-blind, placebo-controlled study which showed that nearly 38 percent of subjects who used sTMS when they had Migraine Headache pain were pain-free two hours after using the device compared to approximately 17 percent of patients in the control group. After 24 hours, approximately 34 percent of the sTMS users were pain-free compared to only 10 percent in the control group. The treatment did not produce any device-related serious adverse events.