BrainsWay's Stimulation Device Scores FDA Approval For Depression Settings

  • The FDA has granted 510(k) clearance to BrainsWay Ltd's BWAY Deep Transcranial Magnetic Stimulation (TMS) H7 Coil for its use in treating adults suffering from major depressive disorder and depression, including those with comorbid anxiety symptoms commonly known as anxious depression.
  • The FDA's grant of clearance was based on its review of successful results from a randomized, double-blind, controlled multicenter trial completed by the Company. 
  • Related: Despite Competition, This Analyst Finds BrainsWay Attractive.
  • The study, which included 144 subjects, found overall efficacy rates for the H7 Coil comparable to those achieved with BrainsWay's H1 Coil.
  • With this new clearance, there is no need to upgrade or add software to systems currently installed in the field. 
  • BrainsWay's Deep TMS H7 Coil, housed within a cushioned, cooled helmet, has been cleared to treat obsessive-compulsive disorder since 2018. 
  • It can now be put to use against depression. The H7 Coil is designed to allow for stimulation of deeper and broader brain structures than traditional TMS coils.
  • Price Action: BWAY shares are up 5.29% at $4.74 on the last check Monday.
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