Latest news with #RonnieStolec-Campo
Yahoo
16-05-2025
- Health
- Yahoo
Magstim Granted EU MDR Certification
Magstim TMS Granted EU MDR Certification Magstim Passes Compliance with Strict European Union Medical Device RegulationsExpanding Magstim Access to Entire EU Marketplace WHITLAND, United Kingdom, May 16, 2025 (GLOBE NEWSWIRE) -- Magstim has been granted EU MDR Certification for all transcranial magnetic stimulation (TMS) systems, demonstrating compliance with strict European Union Medical Device Regulations. This provides a path for Magstim TMS technology to be sold throughout the EU marketplace, and proves that the device is safe, clinically effective and has passed all requirements for testing and traceability. 'The EU MDR is the most rigorous certification backed by verified scientific knowledge,' said Ronnie Stolec-Campo, CEO, Welcony. 'As pioneers of neuromodulation for researchers and clinicians, our team is honoured to build world-class technology to study and treat the brain. This certification allows expanded reach to support this life-saving work.' The European Union Medical Device Regulation (EU MDR) governs the safety, performance, and quality of medical devices sold in the European Economic Area (EEA). It replaced the previous Medical Device Directive (MDD). The certification is issued by a Notified Body, an independent organization designated by an EU member state. 'Our customers can be confident that with this certification, Magstim technology has passed some of the most rigorous quality testing medical devices are subjected to,' said Stolec-Campo. 'The big thank you goes to our internal Welcony teams in Regulatory, R&D and support for your commitment to get this across the line—we know this will help people worldwide.' As the only integrated TMS technology, Magstim is now the only TMS system which can treat MDD, Anxious Depression, OCD, and Adolescent Depression with a single treatment coil. The FDA recently cleared the Magstim Horizon 3.0 and Inspire Transcranial Magnetic Stimulation Systems for treating adolescent patients aged 15-21 for MDD, providing a non-invasive, non-pharmacological technology to improve care. To learn more about the entire family of research and clinical neurotechnology innovations, visit or call 844-624-7846. About Welcony Globally, Welcony technologies have supported thousands of research labs, clinics, hospitals and universities that focus on mental health, brain disorders, cognitive neuroscience and neuromonitoring. Key brands include Magstim Magnetic Stimulation, MagstimEGI high-density EEG, Technomed Clinical Neurophysiology and Neurosign Interoperative Nerve Monitoring. Welcony is backed by Telegraph Hill Partners, a San Francisco based private equity company. Media Contact: Mark Sejvar, msejvar@ 323-363-3530 A photo accompanying this announcement is available at in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Hamilton Spectator
16-05-2025
- Health
- Hamilton Spectator
Magstim Granted EU MDR Certification
Magstim Passes Compliance with Strict European Union Medical Device Regulations Expanding Magstim Access to Entire EU Marketplace WHITLAND, United Kingdom, May 16, 2025 (GLOBE NEWSWIRE) — Magstim has been granted EU MDR Certification for all transcranial magnetic stimulation (TMS) systems, demonstrating compliance with strict European Union Medical Device Regulations. This provides a path for Magstim TMS technology to be sold throughout the EU marketplace, and proves that the device is safe, clinically effective and has passed all requirements for testing and traceability. 'The EU MDR is the most rigorous certification backed by verified scientific knowledge,' said Ronnie Stolec-Campo, CEO, Welcony. 'As pioneers of neuromodulation for researchers and clinicians, our team is honoured to build world-class technology to study and treat the brain. This certification allows expanded reach to support this life-saving work.' The European Union Medical Device Regulation (EU MDR) governs the safety, performance, and quality of medical devices sold in the European Economic Area (EEA). It replaced the previous Medical Device Directive (MDD). The certification is issued by a Notified Body, an independent organization designated by an EU member state. 'Our customers can be confident that with this certification, Magstim technology has passed some of the most rigorous quality testing medical devices are subjected to,' said Stolec-Campo. 'The big thank you goes to our internal Welcony teams in Regulatory, R&D and support for your commitment to get this across the line—we know this will help people worldwide.' As the only integrated TMS technology, Magstim is now the only TMS system which can treat MDD, Anxious Depression, OCD, and Adolescent Depression with a single treatment coil. The FDA recently cleared the Magstim Horizon 3.0 and Inspire Transcranial Magnetic Stimulation Systems for treating adolescent patients aged 15-21 for MDD, providing a non-invasive, non-pharmacological technology to improve care. To learn more about the entire family of research and clinical neurotechnology innovations, visit or call 844-624-7846. About Welcony Globally, Welcony technologies have supported thousands of research labs, clinics, hospitals and universities that focus on mental health, brain disorders, cognitive neuroscience and neuromonitoring. Key brands include Magstim Magnetic Stimulation, MagstimEGI high-density EEG, Technomed Clinical Neurophysiology and Neurosign Interoperative Nerve Monitoring. Welcony is backed by Telegraph Hill Partners, a San Francisco based private equity company. Media Contact: Mark Sejvar, msejvar@ , 323-363-3530 A photo accompanying this announcement is available at
Yahoo
19-03-2025
- Health
- Yahoo
FDA Clears Magstim Transcranial Magnetic Stimulation System for U.S. Adolescent Patient Treatment
Adolescent patients ages 15-21 can now receive non-invasive TMS for treatment of major depressive disorder (MDD)* MINNEAPOLIS, March 19, 2025 (GLOBE NEWSWIRE) -- Major depression impacts more than 5 million U.S. adolescents every year, and NIH data shows that 20% of those aged 12 to 16 have had at least one major depressive episode*. The FDA has now cleared the Magstim Horizon 3.0 and Inspire Transcranial Magnetic Stimulation Systems for treating adolescent patients aged 15-21 for MDD, providing a non-invasive, non-pharmacological technology to improve care. 'For adolescents struggling with depression, treatment options like antidepressants may not work for or be wanted by all patients,' said Dr. Eric Robbins, Blue Umbrella Psychiatry. 'TMS is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of MDD. TMS technology has helped our adult patients improve their quality of life and we are excited to offer this for our adolescent patients.' This FDA clearance for the Magstim Horizon 3.0 and Inspire systems builds on the existing patient TMS clearances for adult patients, making it possible for physicians and nurse practitioners to treat adolescent patients and gain authorization from insurance providers. According to the WHO, adolescence is a crucial period for development, and untreated depression is a leading cause for illness and disability*. 'Adolescents and the health professionals who care for them need support, innovation and tools to treat depression,' said Ronnie Stolec-Campo, CEO, Magstim. 'Through this FDA approval, thousands of adolescent patients with depression will be able to take advantage of our nonpharmacologic advanced technology. Magstim is now the only TMS system which can treat MDD, Anxious Depression, OCD, and Adolescent Depression with a single treatment coil.' Practices with current Magstim Horizon systems can begin treating adolescents immediately, following standard patient care protocols. TMS is a safe and well tolerated treatment that is not associated with any of the systemic side effects typically experienced with antidepressants. Practices in the USA using the Horizon 3.0 system have delivered over Four Hundred Million treatment pulses to address patient mental health. Magstim developed the first TMS system more than 30 years ago; over 16,000 studies published worldwide cite the use of Magstim stimulators. *NIH Source: *WHO Source: *Horizon 3.0 TMS Therapy Systems are indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21) To learn more about Magstim Horizon and the entire family of research and clinical neurotechnology innovations, visit or call 844-624-7846. About Welcony Globally, Welcony technologies have supported thousands of research labs, clinics, hospitals and universities that focus on mental health, brain disorders, cognitive neuroscience and neuromonitoring. Key brands include Magstim Magnetic Stimulation, MagstimEGI high-density EEG, Technomed Clinical Neurophysiology and Neurosign Interoperative Nerve Monitoring. Welcony is backed by Telegraph Hill Partners, a San Francisco based private equity company. CONTACT: Media Contact: Mark Sejvar, 323-363-3530Sign in to access your portfolio
Associated Press
19-03-2025
- Health
- Associated Press
FDA Clears Magstim Transcranial Magnetic Stimulation System for U.S. Adolescent Patient Treatment
MINNEAPOLIS, March 19, 2025 (GLOBE NEWSWIRE) -- Major depression impacts more than 5 million U.S. adolescents every year, and NIH data shows that 20% of those aged 12 to 16 have had at least one major depressive episode*. The FDA has now cleared the Magstim Horizon 3.0 and Inspire Transcranial Magnetic Stimulation Systems for treating adolescent patients aged 15-21 for MDD, providing a non-invasive, non-pharmacological technology to improve care. 'For adolescents struggling with depression, treatment options like antidepressants may not work for or be wanted by all patients,' said Dr. Eric Robbins, Blue Umbrella Psychiatry. 'TMS is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of MDD. TMS technology has helped our adult patients improve their quality of life and we are excited to offer this for our adolescent patients.' This FDA clearance for the Magstim Horizon 3.0 and Inspire systems builds on the existing patient TMS clearances for adult patients, making it possible for physicians and nurse practitioners to treat adolescent patients and gain authorization from insurance providers. According to the WHO, adolescence is a crucial period for development, and untreated depression is a leading cause for illness and disability*. 'Adolescents and the health professionals who care for them need support, innovation and tools to treat depression,' said Ronnie Stolec-Campo, CEO, Magstim. 'Through this FDA approval, thousands of adolescent patients with depression will be able to take advantage of our nonpharmacologic advanced technology. Magstim is now the only TMS system which can treat MDD, Anxious Depression, OCD, and Adolescent Depression with a single treatment coil.' Practices with current Magstim Horizon systems can begin treating adolescents immediately, following standard patient care protocols. TMS is a safe and well tolerated treatment that is not associated with any of the systemic side effects typically experienced with antidepressants. Practices in the USA using the Horizon 3.0 system have delivered over Four Hundred Million treatment pulses to address patient mental health. Magstim developed the first TMS system more than 30 years ago; over 16,000 studies published worldwide cite the use of Magstim stimulators. *Horizon 3.0 TMS Therapy Systems are indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21) To learn more about Magstim Horizon and the entire family of research and clinical neurotechnology innovations, visit or call 844-624-7846. About Welcony Globally, Welcony technologies have supported thousands of research labs, clinics, hospitals and universities that focus on mental health, brain disorders, cognitive neuroscience and neuromonitoring. Key brands include Magstim Magnetic Stimulation, MagstimEGI high-density EEG, Technomed Clinical Neurophysiology and Neurosign Interoperative Nerve Monitoring. Welcony is backed by Telegraph Hill Partners, a San Francisco based private equity company.
