Click Therapeutics’ CT-132 Gets Breakthrough Device Status

The FDA has granted Breakthrough Device status to Click Therapeutics’ CT-132, a prescription therapeutic to prevent episodic migraine in patients 18 years and older.

The investigational product, which uses digital neuroactivation and neurobehavioral interventions to treat migraine without drugs, is currently in clinical studies.

The company is seeking FDA clearance for the device in the Class II category. The FDA assigns the Class II category to devices for which general controls are insufficient to provide reasonable assurance of safety and effectiveness.

The Breakthrough Devices program is intended to provide timely access to medical devices by speeding up their development and review.