Magstim Quality & Regulatory
Magstim is driven to make healthcare better for customers by providing innovative products and services that meet regulatory requirements through our effective quality system.
Aligning closely with our mission and values, we define quality at our organisation through this policy. We stand behind our products and address issues if they arise. To support this, we have a robust quality management system (QMS) certified to MDSAP ISO 13485, to enable collaboration and global agility, maximises efficiency and ensures compliance to local legislative requirements. The Magstim Company Ltd. is committed to delivering high-quality products to customers – this starts with designing quality into our processes and products.
Magstim aims to ensure that our products meet the highest standards of safety and quality. From initial development stages to market entry and ongoing compliance, to ensure our devices adhere to all applicable laws and regulations. With a focus on transparency and diligence, we are committed to upholding the integrity of our products and bring innovative TMS solutions to researchers and patients.
Regulatory Indications
Magstim200 & BiStim
Magstim 2002 is cleared for the stimulation of peripheral nerves for diagnostic use only. Other applications are considered investigational.
Magstim BiStim has not been cleared by the FDA. All uses are considered investigational only and require an IDE/IRB approval.
Rapid TMS Systems
Rapid TMS System(s) are intended to be used for the stimulation of peripheral nerves
Rapid TMS System(s) are intended to be used for the treatment of Major Depressive Disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode
Rapid2 Magnetic Stimulators (Magstim Rapid², Magstim Super Rapid², Magstim Super Rapid² Plus¹) are intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years and older.
Horizon TMS Systems
The Horizon® TMS Therapy System is indicated for the treatment of Major Depressive Disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
For Adults: Horizon 3.0 TMS Therapy Systems are indicated for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
For Adolescents: Horizon 3.0 TMS Therapy Systems are indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21).
Magstim Research & Therapy Coils
Coils are accessories to their compatible stimulator systems; Rapid² TMS Systems and Magstim 200² & BiStim² TMS Systems. As such, the indications for use is dictated by these compatible systems.
Magstim200 & BiStim
Magstim 2002 and Bistim2 TMS Systems, and their compatible coils, are indicated for stimulation of the human cortex in adult ischemic and haemorrhagic stroke patients to generate Motor Evoked Potentials for the assessment of upper limbs as an aid in prognosis of motor function recovery.
Rapid TMS Systems
Rapid TMS System(s) when used together with AFC Coil and MT Coil are intended to be used for the treatment of Major Depressive Disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Rapid TMS System(s) when used together with AFC Coil and MT Coil are intended as an adjunct for the treatment of adult patients suffering from Obsessive Compulsive Disorder (OCD).
Rapid TMS System(s) when used together with AFC Coil and MT Coil are indicated for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder, or generalised anxiety symptoms, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Rapid TMS System(s) when used Magstim Research and Therapy Coils are intended for repetitive transcranial magnetic stimulation of peripheral nerves and the human cortex for research purposes only
Rapid TMS System(s) when used together with AFC Coil and MT Coil are indicated for the (Short-term) relief of chronic neuropathic pain in adult patients.
Horizon TMS Systems
Horizon TMS Systems, and their compatible coils, are intended to be used for the treatment of Major Depressive Disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Horizon TMS Systems, and their compatible coils, are intended as an adjunct for the treatment of adult patients suffering from Obsessive Compulsive Disorder (OCD).
Horizon TMS Systems, and their compatible coils, are indicated for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder, or generalised anxiety symptoms, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Horizon TMS System(s), and their compatible coils, are indicated for (short-term) relief of chronic
neuropathic pain in adult patients.
Magstim Research & Therapy Coils
Coils are accessories to their compatible stimulator systems; Rapid² TMS Systems and Magstim 200² & BiStim² TMS Systems. As such, the indications for use is dictated by these compatible systems.
Magstim 2002 and Bistim2 TMS Systems, and their compatible coils, are indicated for stimulation of the human cortex in adult ischemic and haemorrhagic stroke patients to generate Motor Evoked Potentials for the assessment of upper limbs as an aid in prognosis of motor function recovery.
The Rapid® TMS System(s) when used Magstim Research and Therapy Coils are intended for repetitive transcranial magnetic stimulation of peripheral nerves and the human cortex for research purposes only.
Magstim200 & BiStim
Magstim 2002 and Bistim2 TMS Systems, and their compatible coils, are indicated for stimulation of the human cortex in adult ischemic and haemorrhagic stroke patients to generate Motor Evoked Potentials for the assessment of upper limbs as an aid in prognosis of motor function recovery.
Rapid TMS Systems
Rapid TMS System(s) when used together with AFC Coil and MT Coil are intended to be used for the treatment of Major Depressive Disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Rapid TMS System(s) when used together with AFC Coil and MT Coil are intended as an adjunct for the treatment of adult patients suffering from Obsessive Compulsive Disorder (OCD).
Rapid TMS System(s) when used together with AFC Coil and MT Coil are indicated for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder, or generalised anxiety symptoms, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Rapid TMS System(s) when used Magstim Research and Therapy Coils are intended for repetitive transcranial magnetic stimulation of peripheral nerves and the human cortex for research purposes only
Rapid TMS System(s) when used together with AFC Coil and MT Coil are indicated for the (Short-term) relief of chronic neuropathic pain in adult patients.
Horizon TMS Systems
Horizon TMS Systems, and their compatible coils, are intended to be used for the treatment of Major Depressive Disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Horizon TMS Systems, and their compatible coils, are intended as an adjunct for the treatment of adult patients suffering from Obsessive Compulsive Disorder (OCD).
Horizon TMS Systems, and their compatible coils, are indicated for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder, or generalised anxiety symptoms, who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Horizon TMS System(s), and their compatible coils, are indicated for (short-term) relief of chronic
neuropathic pain in adult patients.
Magstim Research & Therapy Coils
Coils are accessories to their compatible stimulator systems; Rapid² TMS Systems and Magstim 200² & BiStim² TMS Systems. As such, the indications for use is dictated by these compatible systems.
Magstim 2002 and Bistim2 TMS Systems, and their compatible coils, are indicated for stimulation of the human cortex in adult ischemic and haemorrhagic stroke patients to generate Motor Evoked Potentials for the assessment of upper limbs as an aid in prognosis of motor function recovery.
The Rapid® TMS System(s) when used Magstim Research and Therapy Coils are intended for repetitive transcranial magnetic stimulation of peripheral nerves and the human cortex for research purposes only.
Magstim 2002 and Bistim2 TMS Systems
Magstim2002 and Bistim2 and their compatible Magstim Class II Research and Therapy Coils are indicated for use as a nerve stimulator with built-in evoked potential recording. Intended for assessment of neurological and muscular function in adult populations.
Rapid TMS Systems
The Rapid TMS System when used together with AFC Coil and MT Coil are indicated for nerve stimulation with built-in evoked potential recording. Intended for assessment of neurological and muscular function in adult and paediatric populations.
Horizon TMS Systems
Horizon TMS Therapy Systems are 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. Furthermore, it is intended to be used for the stimulation of peripheral nerves and the human cortex for the investigation of anatomy, physiology and potential therapeutic effects.
The Horizon 3.0 TMS Therapy System(s) are indicated for the treatment of Major Depressive Disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Magstim Research & Therapy Coils
Coils are accessories to their compatible stimulator systems; Rapid² TMS Systems and Magstim 200² & BiStim² TMS Systems. As such, the indications for use is dictated by these compatible systems.