London-based Livanova plc. has petitioned the U.S. CMS to cover vagus nerve stimulation device for treatment-resistant depression without the need for a clinical trial — a change that would eliminate the costly and cumbersome coverage with evidence development mechanism.
New research confirmed long-term efficacy and safety of a novel minimally invasive procedure with Insightec Inc.’s Exablate transcanial magnetic resonance-guided focused ultrasound system to alleviate symptoms of severe obsessive-compulsive disorder.
In breaking news, Wave Neuroscience LLC received breakthrough device designation from the U.S. FDA for its magnetic electroencephalogram resonance therapy for adjunctive treatment of post-traumatic stress disorder (PTSD), making its technology the first medical device approved to treat the debilitating condition, the company said.
Quantalx Neuroscience Ltd. filed for protection of a system and method for the diagnosis of normal pressure hydrocephalus and prediction of patient response to ventriculoperitoneal shunting surgery treatment. The U.S. FDA granted the company’s Delphi-MD breakthrough device designation for these indications in May 2023.
The U.S. FDA granted Neuronetics Inc. clearance for use of its Neurostar advanced therapy as an adjunctive treatment of major depressive disorder in patients aged 15 to 21, making it the first transcranial magnetic stimulation treatment (TMS) cleared for this age group, the company said.
Researchers from the University of Maryland Baltimore and University of Maryland Baltimore County are seeking patent protection for an angle-tuned (AT) ring coil for improving the depth-spread performance of transcranial magnetic stimulation (TMS) coils as well as high-performance composite coils and multisite TMS systems.
Neuronetics Inc. gained expanded approval in Japan for its transcranial magnetic stimulation (TMS) system to treat major depressive disorder called the Neurostar TMS, helping the Malvern, Pa.-based company increase its footprint in Asia.
Wave Neuroscience Inc. is seeking patent protection for systems and methods for determining and optimizing the alpha burst parameters associated with a subject's brain.
The first participants are being treated in a clinical trial assessing a neuromodulation system developed by Magnus Medical Inc. to treat depression. The system employs the recently FDA-cleared Saint neuromodulation technology that saw remarkable results in a clinical trial for treating major depressive disorder (MDD). The new Open Label Optimization (OLO) clinical trial is evaluating the effectiveness of this platform in conjunction with the medtech’s Magnus Neuromodulation System.
Magstim Inc. received U.S. FDA clearance for use of its Horizon 3.0 and E-z Cool Coil to treat adult patients diagnosed with both obsessive compulsive disorder (OCD) and major depressive disorder (MDD). The company’s non-invasive transcranial magnetic stimulation (TMS) therapy offers an option for patients who do not find adequate relief from the often life-disrupting symptoms of OCD with exposure therapy or medication.
