Magstim receives FDA 510(k) clearance for transcranial magnetic stimulation platform

The FDA has granted 510(k) clearance to neuroscience research and mental health treatment company Magstim for Horizon 3.0, its transcranial magnetic stimulation platform.

The latest Horizon update offers enhanced workflows with navigated transcranial stimulation and analytics for a clinical setting. It utilizes Magstim Connect, a patient data management system for transcranial magnetic stimulation (TMS) that delivers connected care at networked sites.

“We spoke with physicians, patients, researchers and employees and asked them to imagine the next-generation of TMS technology,” Magstim CEO Lothar Krinke, PhD, said in a press release. “How can we improve patient care efficacy and efficiencies? Horizon 3.0 is the culmination of Magstim’s foundation in science, technology and our passion to improve patient outcomes.”

Since Magstim offered its initial TMS system more than 3 decades ago, approximately 16,000 published studies have cited usage of Magstim Stimulators in neuroscientific and clinical research.

“Our TMS patients have experienced a high degree of success, allowing them to change their lives,” Khaled Bowarshi, MD, of Florida TMS Clinic, said in the release. “We strive to provide the best technology for our patients. I can now, with confidence, crown Magstim’s Horizon 3.0 with StimGuide+ to be the best TMS system on the market today.”

The FDA clearance will allow Magstim to distribute Horizon 3.0 to thousands of physicians and clinicians across the U.S.