Brainsway has registered for an upcoming initial public offering, looking to bring in $30 million to support its transcranial magnetic stimulation tech, according to a recently posed SEC filing. The Israel-based company said that it plans to list on the Nasdaq Global Market under the symbol “BWAY,” according to the filing. Brainsway develops and supports […]
IschemaView wins expanded FDA nod for Rapid neuroimager
Medical imaging dev IschemaView said today that it won expanded FDA clearance for its Rapid neuroimaging platform intended for use in selecting patients likely to benefit from endovascular thrombectomy. With the clearance, the Menlo Park, Calif.-based company said that its Rapid CT-Perfusion and Rapid MR-Perfusion devices can now be used to aid in selecting acute […]
Neuromodulation: Using the brain’s internal language to relieve pain
When a patient walks into Dr. Jason Yong’s clinic at Brigham & Women‘s Faulkner Hospital complaining of pain, his work has just begun. “Pain is a common symptom and it’s totally generic,” Yong explained to MassDevice. “The other thing that makes it challenging is that it’s so subjective.” After Yong exhausts the pharmaceutical possibilities for […]
Researchers question use of antibiotic shunts in hydrocephalus patients
Led by neurosurgeon Dr. Benjamin Warf, a team of researchers from Boston Children’s Hospital published a study this month questioning the benefits of using shunts impregnated with antibiotics to treat hydrocephalus. Hydrocephalus, which affects roughly 400,000 children each year, is characterized by fluid accumulation in the brain. Surgeons use shunts to drain the patient’s excess fluid and antibiotic shunts […]
Amneal wins FDA nod for generic rivastigmine transdermal patch
Amneal Pharmaceuticals (NYSE:AMRX) said today that it won FDA approval for a generic rivastigmine transdermal patch. The drug, which is sold under the brand name Exelon, is an acetylcholinesterase inhibitor that is commonly used to treat mild to moderate Alzheimer’s disease and Parkinson’s disease. Get the full story at our sister site, Drug Delivery Business News.
IRRAS: Intracranial bleeding management device used on first U.S. patient
IRRAS AB announced today that a healthcare team in Southern California is the first to use the company’s IRRAflow device on a U.S. patient with intracranial bleeding. A University of California–Irvine (UCI) Medical Center team led by Dr. Sumeet Vadera successfully treated a patient who suffered a chronic subdural hematoma after a recent fall. The IRRAflow device – FDA […]
Empatica’s pediatric seizure-predicting smartband wins FDA nod
Empatica said that its Embrace epilepsy smartband has received 510(k) clearance from FDA for use in children, a year after winning clearance for adults with epilepsy. Embrace was designed to detect motion patterns and physiological signals that may be associated with generalized tonic-clonic (“grand mal”) seizures and immediately alert caregivers. It is the first non-EEG based, […]
FDA: Medtronic select recall of Synergy, Stealth Station S7 cranial software is Class 1
Medtronic (NYSE:MDT) is recalling select Synergy and StealthStation S7 cranial software used with its StealthStation surgical navigation system over reports of incorrect information being displayed during biopsy procedures in a recall action labeled by the FDA as Class I. Class I designations, the FDA’s most severe classification, are used when there is a reasonable probability that […]
Sandoz, Pear launch digital therapy for opioid use disorder
Novartis (NYSE:NVS) division Sandoz and Pear Therapeutics this week kicked off the U.S. commercial launch of the first FDA-cleared prescription digital therapy for people with opioid use disorder. The companies partnered to commercialize a 12-week cognitive behavioral therapy intended to be used in tandem with outpatient treatment. The therapy includes transmucosal buprenorphine and contingency management designed to reinforce positive behaviors, […]
Nobilis files IND for trial to study drug-device PTSD therapy
Nobilis Therapeutics said yesterday that it filed an investigational new drug application with the FDA to kick off a Phase IIb trial of its NBTX-001 drug-device PTSD therapy. The Portland, Ore.-based company is developing a portable inhalation device designed to deliver a xenon gas mixture. Get the full story at our sister site, Drug Delivery Business […]
Terumo’s MicroVention wins FDA approval for Web brain aneurysm device
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today that it won pre-market approval from the FDA for the Web brain aneurysm device it acquired when it bought Sequent Medical back in 2016. Aliso Viejo, Calif.-based MicroVention said the PMA for the Web embolic coil covers the treatment of intracranial wide neck bifurcation aneurysms. “We are proud to offer […]
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