Phagenesis Ltd. reported real-world data showing its Phagenyx system provides significant benefits in the treatment of patients with dysphagia, or difficulty swallowing, due to a variety of causes.
Abbott Laboratories has seen the launch of the IonicRF Generator, which delivers a nonsurgical, minimally invasive treatment for the management of pain in the nervous system. The generator is a radiofrequency (RF) ablation device that uses heat to target specific nerves and block pain signals from reaching the brain. The launch of Abbott's IonicRF Generator looks to help the estimated 50 million people in the U.S. currently living with chronic pain.
The U.S. FDA has given its nod to a new solution that aims to help with the temporary reduction of sleep disturbance related to nightmares in certain people. Specifically, the agency reviewed the device, from Minneapolis-based Nightware Inc., through the de novo premarket review pathway and now is permitting its use in patients aged 22 years of age or older who are suffering from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). The agency previously granted the solution breakthrough device designation.
Keeping you up to date on recent developments in neurology, including: AI helps detect brain aneurysms on CT angiography; BBB studies advancing focused ultrasound treatment for Parkinson’s; Study reveals unexpected protective role for brain swelling after injury.
PARIS – Oncomfort SA has entered a partnership with Vygon SA for distribution of its Sedakit in six countries in Europe. The synergy between Vygon’s specialization and Oncomfort’s fields of application aims to enable greater acceleration of the adoption of Digital Sedation by health care professionals and patients. “Thanks to this strategic partnership, our new technology for relieving patient pain and anxiety without medication is going to be widely available in Europe,” Mario Huyghe, CEO of Oncomfort, told BioWorld.
The U.S. FDA has granted breakthrough device designation to Salvia Bioelectronics BV for its implantable neurostimulation system to treat chronic migraine. The designation, which provides for priority review and consultation with the agency on product development, underscores the need for effective treatments for the costly and debilitating condition. According to a summary in a patent filing, the wireless system comprises a treatment pulse generator unit and an implantable electrode unit to provide neurostimulation therapy for headaches.
HONG KONG – Aprinoia Therapeutics Inc. is poised to start phase III clinical trials for its positron emission tomography (PET) imaging tracer 18F-APN-1607 in China, after receiving the green light from the National Medical Products Administration.
Keeping you up to date on recent developments in neurology, including: Software developed to objectively calculate white matter hyperintensities; CSF biomarkers point to underlying cause of neural damage in COVID-19; Scientists discover how cryptochrome mutation leads to sleep disorder; Physical labor significantly increases the risk of dementia.
Neuroem Therapeutics Inc. has received breakthrough device designation from the U.S. FDA for Memorem, a bioengineered, wearable head device for the treatment of Alzheimer’s disease. The breakthrough nod, which entitles companies to an expedited regulatory process, follows results from a pilot study showing Memorem can reverse memory loss in patients with the debilitating brain disorder.
PERTH, Australia – Neuroscience technology company Cogstate Ltd. and Japanese pharmaceutical company Eisai Co. Ltd. signed a deal under which Eisai will have global development rights and exclusive commercialization rights of all cognitive function tests developed by Cogstate, including the Cogstate Brief Battery (CBB) for use in health care and other markets.
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