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Neurological

FDA clears Theranica device for adolescent migraines

January 25, 2021 By Nancy Crotti Leave a Comment

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 […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Neurological, Neuromodulation/Neurostimulation, Pain Management, Regulatory/Compliance Tagged With: FDA, Theranica Bio-Electronics

FDA approves Boston Scientific Vercise Genus deep brain stimulation system

January 22, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Bioelectronic Medicine, Featured, Food & Drug Administration (FDA), Neurological, Neuromodulation/Neurostimulation, Regulatory/Compliance Tagged With: Boston Scientific, FDA

Medtronic launches deep brain stim trial for Parkinson’s disease

January 15, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Clinical Trials, Neurological, Neuromodulation/Neurostimulation Tagged With: Medtronic

Boston Scientific’s preliminary Q4 results show 6.8% revenue decline

January 12, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Cardiac Implants, Cardiovascular, Featured, MassDevice Earnings Roundup, Neurological, Neuromodulation/Neurostimulation, Structural Heart, Wall Street Beat Tagged With: Boston Scientific

FDA approves low-profile aneurysm embolization system

January 12, 2021 By Sean Whooley

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Neurological, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: MicroVention-Terumo Inc., Terumo

ClearMind neuroendoscope gains FDA clearance

January 11, 2021 By Sean Whooley

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 […]

Filed Under: Endoscopic, Food & Drug Administration (FDA), Imaging, Neurological, Regulatory/Compliance, Surgical Tagged With: ClearMind Biomedical, FDA

Penumbra on track for higher Q4 revenue

January 11, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, Neurological, Vascular, Wall Street Beat Tagged With: Penumbra

Apple, Biogen partner on using smart devices to track cognitive health

January 11, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Clinical Trials, Featured, Health Technology, Neurological, Software / IT Tagged With: Apple, Biogen

Abbott gains FDA clearance for rapid concussion test

January 11, 2021 By Sean Whooley

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 […]

Filed Under: 510(k), Diagnostics, Featured, Food & Drug Administration (FDA), Neurological, Regulatory/Compliance Tagged With: Abbott, FDA

NeuroOne Medical appoints new CFO

January 7, 2021 By Sean Whooley

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 […]

Filed Under: Bioelectronic Medicine, Business/Financial News, Featured, Neurological, Neuromodulation/Neurostimulation, Pain Management Tagged With: neuroone, Personnel Moves

MicroVention suing Balt

December 23, 2020 By Sean Whooley

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 […]

Filed Under: Featured, Legal News, Neurological Tagged With: Balt, MicroVention-Terumo Inc., Terumo

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