Why BWAY surged over 20% today during premarket hours? The stock price of BrainsWay Ltd. (NASDAQ & TASE: BWAY) experienced a major increase to more than 20% today during the premarket hours. Here is what you know about it. On August 29th, at 8:00 EST, BrainsWay Ltd. (NASDAQ & TASE: BWAY) announced the receipt of FDA 510(k) clearance for the Company’s Deep TMS™ H7 Coil. The therapy is for treating adults suffering from major depressive disorder and depression, including those with comorbid anxiety symptoms commonly known as anxious depression. The traders and investors found the news appealing, and its stock price surged over 20% in less than an hour. BrainsWay Ltd. (NASDAQ & TASE: BWAY) is a leading company in advanced noninvasive neurostimulation treatments for mental health disorders. The importance of the clearance lies in BrainsWay’s pursuit of refining and optimizing noninvasive options for treatment-resistant mental health conditions. Expanding depression clearance to the Deep TMS H7 Coil provides clinicians with another powerful non-pharmaceutical tool, allowing them to have myriad pharmaceutical options to tailor treatment plans for their patients. TMS treatment for depression is not a one-size-fits-all solution with respect to all anatomical targets: The H1 Coil targets one region of the brain, and the H7 Coil targets a different region, and they see that stimulating either of these regions can mitigate depressive symptoms. This clearance may advance the goal of enabling clinicians to provide more personalized medicine for their patients depending on what works best for them. The successful results from a randomized, double-blind, controlled multicenter trial completed by the Company brought them the FDA’s grant of clearance. The trial was designed to understand better the H7 Coil’s efficacy in addressing treatment-resistant depression. Because of this clearance, there is no need to upgrade or add software to systems currently installed in the field. Now the designed device can be put to use to treat obsessive-compulsive disorder and depression. The H7 Coil is designed to allow for stimulation of more profound and broader brain structures than traditional TMS coils.