Theranica announced today that the FDA has granted expanded clearance for the use of its Nerivio acute migraine treatment device by people 12 years and older. The use of the device in the treatment of adolescents is supported by a study recently published in Headache. According to the study, 28 of 39 (71%) of the adolescent participants using […]
Neurological
FDA approves Boston Scientific Vercise Genus deep brain stimulation system
Boston Scientific (NYSE:BSX) announced today that it received FDA approval for its fourth-generation Vercise Genus DBS system. Marlborough, Mass.-based Boston Scientific’s Vercise Genus deep brain stimulation (DBS) system portfolio is approved for conditional use in a magnetic resonance imaging (MRI) environment. It features a family of Bluetooth-enabled, rechargeable and non-rechargeable implantable pulse generators capable of powering […]
Medtronic launches deep brain stim trial for Parkinson’s disease
Medtronic (NYSE:MDT) announced that it made the first enrollment in the Adapt-PD trial for adaptive deep brain stimulation. Fridley, Minn.-based Medtronic’s Adapt-PD trial is evaluating the safety and efficacy of aDBS in patients with Parkinson’s Disease, according to a news release. If approved, aDBS could be enabled as an investigational feature of the Percept PC device […]
Boston Scientific’s preliminary Q4 results show 6.8% revenue decline
Boston Scientific (NYSE:BSX) announced today that its fourth-quarter net sales represent an approximate decline of 6.8% year-over-year. Marlborough, Mass.-based Boston Scientific’s estimation of $2.71 billion in fourth-quarter revenue brings its full-year 2020 sales total to approximately $9.91 billion, marking a 7.7% total decline from 2019. Wall Street analysts on average had predicted $2.86 billion in revenue […]
FDA approves low-profile aneurysm embolization system
Terumo (TYO:4543) subsidiary MicroVention announced today that it received FDA approval of a PMA supplement for its WEB 17 system. Aliso Viejo, Calif.-based MicroVention’s WEB 17 system is a new addition to its WEB aneurysm embolization system for treating intracranial wide-neck bifurcation aneurysms, according to a news release. WEB 17 features a lower profile delivery system compatible […]
ClearMind neuroendoscope gains FDA clearance
ClearMind Biomedical announced today that it received FDA clearance for its Axonpen novel neuroendoscope system. Los Angeles-based ClearMind Biomedical’s Axonpen system is designed for the illumination and visualization of intracranial tissue and fluids, as well as the controlled aspiration of tissue and/or fluid during surgery, according to a news release. The system requires a 6.5 […]
Penumbra on track for higher Q4 revenue
Penumbra (NYSE:PEN) announced today that it expects more than 10% year-over-year sales growth in its fourth-quarter financial results. In its preliminary results, Penumbra expects revenues in the range of $162.5 million to $167.9 million, marking growth of between 12% and 16% when compared to 2019, according to a news release. Within those figures, Alameda Calif.-based Penumbra […]
Apple, Biogen partner on using smart devices to track cognitive health
Biogen (NSDQ:BIIB) today announced a virtual research study in collaboration with Apple (NSDQ:AAPL) for monitoring and screening cognitive health. The multi-year, observational research study, set to be launched later this year, is slated to investigate the role Apple Watch and iPhone could play in monitoring cognitive performance and screening for a decline in cognitive health, including […]
Abbott gains FDA clearance for rapid concussion test
Abbott (NYSE:ABT) announced today that it received FDA 510(k) clearance for its rapid handheld traumatic brain injury (TBI) blood test. According to a news release, the test is designed to help clinicians assess individuals with suspected mild TBIs, including concussions. The test runs on Abbott’s handheld i-STAT Alinity platform, with results provided within 15 minutes after […]
NeuroOne Medical appoints new CFO
NeuroOne Medical Technologies (OTC:NMTC) announced today that it appointed Ronald McClurg as its chief financial officer. McClurg, a veteran of 30 years in the space of financial leadership, has held the role of CFO for companies including Orthomet, Incisive Surgical, Video Sentry and Insignia Systems, having begun his career in public accounting at Ernst and […]
MicroVention suing Balt
Terumo (TYO:4543) subsidiary MicroVention announced today that it filed a second lawsuit against Balt USA for trade secret misappropriation. Aliso Viejo, Calif.-based MicroVention’s second lawsuit against Balt and four former employees follows an earlier patent lawsuit that is still ongoing, having been filed in July 2019, according to a news release. MicroVention alleges that, during the discovery […]
