The Apollo TMS therapy system is developed and manufactured in Germany by MAG & More, a TMS specialist with more than 15 years of experience in the field. Apollo is designed to make TMS therapy easy and intuitive to use for the operator and accomplishes this with the HANS positioning system and touch based Patient Management System. In May 2018, Apollo received FDA clearance for the 37.5 and 19 minutes treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.”
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The following TMS systems have been cleared by the FDA to treat Major Depression.
Blossom TMS™️ Therapy System
Blossom TMS™️ Therapy System from SEBERS Medical Inc. integrates user-friendliness and reliability into a sophisticated therapy station. The motto "We make TMS easy" is 100% reflected in the Blossom TMS™️ Therapy System. In particular, the ease of use is unique and exemplary. SEBERS Medical specializes in devices specifically designed for the therapy of patients with mental disorders and distributes medical devices in 20+ countries. The Blossom TMS™️ Therapy System has received FDA clearance for the 37.5 and 19 minutes treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
BrainsWay Deep TMS
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first TMS company to obtain three unique FDA-cleared indications. Deep TMS remains the only TMS treatment with pivotal clinical studies for obsessive-compulsive disorder and smoking addiction demonstrating efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS.
CloudTMS is manufactured by Neurosoft, Ltd. a global leader in the development of TMS devices since 1996 with thousands of TMS machines operated in psychiatric and neurological clinics in the US and around the world. The CloudTMS system has received FDA clearance for the 37.5 and 19 minutes treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. CloudTMS has an installed customer base of over 1500 devices worldwide and received regulatory clearances in more than 25 countries.
Magstim is the Brains behind TMS. Magstim pioneered Transcranial Magnetic Stimulation technology over 25 years ago. In 2019, Magstim received FDA clearance for StimGuide, the first TMS navigation system developed specifically for the clinical setting. StimGuide provides simple, precise and consistent coil positioning using 4 parameters to guide you to your specific target. Also in 2019, Magstim received 510k clearance for the iTBS 3-minute protocol. In 2018, Magstim received FDA clearance for the Horizon Performance System, our next generation TMS Therapy offering, which features the Energy Recovery System, (ERS). The proprietary ERS software ensures consistent stimulation throughout a treatment with no pulse decay. Horizon is cleared for the 3-minute, 19-minute and 37.5 minute protocols and is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Magstim received its initial FDA 510 (k) clearance to market the Rapid2 Therapy System in 2015.
MagVenture TMS Therapy
MagVenture TMS Therapy® was used for the world’s largest RCT with TMS to date (Blumberger et al, 2018, The Lancet: “THREE-D: a randomised non-inferiority trial”), comparing the standard, 37 minute TMS protocol to the newer, 3 minute Theta Burst protocol. The study concluded that the Theta Burst protocol is just as safe and effective for the treatment of major depressive disorder as standard TMS. In 2018, MagVenture received FDA clearance for the 3 minute protocol which we market under the trademarked name Express TMS®. MagVenture is also FDA cleared for the standard 37 minute protocol as well as the 19 minute protocol. MagVenture has a long-standing legacy within the neuroscience community, providing TMS solutions to researchers since 1992. We are confident that new treatment options and discoveries will emerge as our knowledge of the human brain increases and the research matures enough to establish the efficacy and safety of a given application.
Neurostar Advanced Therapy
Neuronetics, Inc. is the market leader in TMS with NeuroStar Advanced Therapy. In 2008 NeuroStar was the first TMS treatment to be cleared by the FDA for treatment of depression. Since that time over 4.5 million NeuroStar Advanced TMS treatments have been performed in more than 120,00 patients. In a retrospective study of real-world patient outcomes, 83% of people completing NeuroStar treatment reported measurable relief, and 62% of those completing treatment achieved remission.
NeuroStar’s safety and efficacy is backed by the largest clinical data set in depression, including the world’s largest depression outcomes registry, 15 studies with over 1,000 patients, and 29 peer-reviewed publications. NeuroStar is the only TMS with clinically-proven durability through 12 months. Neuronetics’ commitment to advancing the science of TMS has also been demonstrated in over 65 investigator-initiated trials, involving more than 1,900 patients.
To personalize TMS for the treatment of MDD, Nexstim has developed SmartFocus™ technology. The Nexstim® NBT System 2 allows the physician to define the TMS target from a patient’s MRI scan and have visual confirmation that therapy is always on-target. SmartFocus™ uniquely allows the physician to personalize the TMS target and dose—and uniquely ensures that repeat TMS treatments are targeted to the prefrontal cortex with the precision demanded by neurosurgeons for preprocedural planning.