LivaNova (NSDQ:LIVN) said today it won CE Mark in the European Union for its Vagus Nerve Stimulation Therapy system, now indicated for treating patients with drug-resistant epilepsy. The VNS Therapy system is composed of the London-based company’s SenTiva implantable generator and a next-gen VNS therapy programming system. LivaNova touted the SenTiva generator as the smallest and […]
In reversal, FDA accepts Alkermes’ depression drug for review
In an about-face, the FDA reportedly agreed to review a new drug application for Alkermes‘ (NSDQ:ALKS) depression drug just weeks after the agency said it would only do so if the company conducted additional trials. Alkermes’ once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with major depressive disorder […]
Soterix touts transcranial stim depression trial results
Soterix Medical today released results from trials of its direct current stimulation-limited total energy technology designed to treat depression, touting that the device was found to be safe and effective with improvements in depression-rating metrics lasting for a month after treatment. The tDCS-LTE system is designed to deliver energy to the dorsolateral prefrontal cortex region […]
Jan Medical begins coop BrainPulse testing with the US Army
Jan Medical said today that it has launched a cooperative research and development deal with the US Army Medical Materiel Agency to evaluate its BrainPulse device. Jan Medical’s BrainPulse device is designed to non-invasively capture novel physiological signals through a patient’s cardiac output, used to measure vascular and brain tissue conditions, the company said. The data […]
Medtronic wins CE Mark for Visualase brain surgery device
Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for its Visualase brain surgery device. Fridley, Minn.-based Medtronic said the MRI-guided Visualase system uses a small-diameter probe to deliver laser energy to ablate soft tissue in the brain. It’s been approved in the U.S. since 2007, the company said. “The introduction […]
Study: PET imaging agent could help predict depression drug’s efficacy
Researchers have identified a positron emission tomography imaging agent that could identify the patients that are more likely to benefit from a drug designed to treat major depressive disorder, according to a study published this month in The Journal of Nuclear Medicine. The C-DASB tracer targets a protein, 5-HTT, found in the part of a person’s […]
DARPA is developing a human memory prosthesis: Here’s how
The Defense Advanced Research Projects Agency (DARPA) has successfully created what it is calling a human memory prosthesis, a system with electrodes implanted in the brain that restores memory function using a person’s own neural codes. DARPA has been working on restoring normal memory function in military personnel since 2013 in a program known as […]
BD’s C.R. Bard must pay $4m in IVC bellwether
Becton Dickinson & Co.’s (NYSE:BDX) C.R. Bard (NYSE:BCR) is on the hook for $3.6 million in damages after a federal jury in Phoenix found Bard liable for damages caused by inferior vena cava filtering devices. The case is the first bellwether trial out of more than 3,000 suits which have been filed against Bard related to IVC […]
Brainomix raises $10m for AI stroke imaging tech
Brainomix said today that it raised nearly $10 million for the e-ASPECTS stroke imaging technology it’s developing using artificial intelligence. The £7 million round was led by Parkwalk Advisors, joined by existing backers Chimera Partners and Oxford University Innovation Fund and the venture arm of pharma giant Boehringer Ingelheim. Oxford, England-based Brainomix said its tech is […]
Sunovion seeks FDA nod for sublingual film to treat Parkinson’s disease
Sunovion Pharmaceuticals submitted a new drug application to the FDA this week for its apomorphine sublingual film designed to treat motor fluctuations experienced by people with Parkinson’s disease. The Marlborough, Mass.-based company is testing the film as a therapy for Parkinson’s patients experiencing “off” episodes – when symptoms that are otherwise controlled by medications resurface. As […]
InspireMD wins Peruvian nod for CGuard, MGuard
InspireMD (NYSE:NSPR) said yesterday it won regulatory approval from Peru’s Ministry of Health for its CGuard embolic prevention system and MGuard Prime. The Israel-based company said it inked an exclusive distribution agreement with Peru-based medical device distributor Dispositivos Medicos E.I.R.L. “We have been working closely with InspireMD in order to educate key opinion leaders and top hospital […]
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