Axonics (Nasdaq:AXNX) announced today that it received CE mark approval for its R20 rechargeable sacral neuromodulation (SNM) system. The implantable system provides therapy for patients suffering from overactive bladder or fecal incontinence. Axonics won FDA approval for this generation of the R20 in January 2023. The R20 neurostimulator uses the same small 5cc form factor […]
Neurological
Welcome to MassDevice's Neurological Hub, your resource for the latest news in the neurological device space. Stay informed about the innovations and business news shaping the neurological industry.
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Neuromodulation/Neurostimulation | Bioelectronic Medicine | Pain Management | Brain-Computer Interfaces
Here are the top neurological device features from MassDevice and its sister publications (and scroll down to read the latest cardiology device news from MassDevice):
+ 7 brain-computer interface companies you need to know
+ Brain breakthroughs: Aprinoia Therapeutics’ harnesses AI and strategic partnerships to propel neurodegenerative disease research
+ Natalizumab and PML: The complex dance of benefit and risk for MS
Latest Neurological News
SetPoint Medical wins FDA breakthrough nod for nerve stim tech for multiple sclerosis
SetPoint Medical announced today that received FDA breakthrough device designation for its novel neuroimmune modulation platform. Valencia, California–based SetPoint designed its nerve modulation technology for people with relapsing-remitting multiple sclerosis (RRMS). Breakthrough designation enables more communication and priority regulatory review with the FDA. Plus, it supports reimbursement and patient access upon approval. This isn’t the […]
Sooma raises $5.5M for depression-treating neuromod
Sooma Medical announced today that it raised €5 million ($5.5 million) to support its at-home brain stimulation technology. Nordic early-stage investor, Voima Ventures, led the funding round. Singapore-based Verge HealthTech Fund and existing investor Stephen Industries also participated. The funding marks a new phase of growth for Sooma in its mission, the company said in […]
ClearPoint Neuro reports positive laser therapy results
ClearPoint Neuro (Nasdaq:CLPT) today announced preclinical results highlighting the accuracy of its Prism neuro laser therapy system. The Prism system features the only non-cooled laser applicator on the market, the company said. Its next-generation laser applicator technology eliminates the need for external cooling. This simplifies setup, reduces power and ablation time and lessens imaging artifact […]
FDA accepts Onward BCI into advisory program
Onward Medical announced today that the FDA accepted it into its new Total Product Lifecycle Advisory Program (TAP) — a move that could boost the development of Onward’s BCI technology. Acceptance into the TAP program comes on the heels of FDA breakthrough device designation for the ARC-BCI system last month. Breakthrough device designation is a […]
Medtronic has a serious catheter tubing recall
The FDA today designated a Medtronic recall of Duet external drainage and monitoring system catheter tubing as Class I, its most serious level. Medtronic Neurosurgery initiated the recall on Jan. 22. According to the FDA, it involves 45,176 devices distributed from May 3, 2021, to Jan. 9, 2024. The model numbers involved are 46913, 46914, […]
Nanoflex Robotics announces first U.S. surgical robot installation
Nanoflex Robotics announced today that it installed its first remote-ready robotics system for neurovascular procedures in the U.S. The installation took place at The Jacobs Institute, a nonprofit medical device innovation center in Buffalo, New York. Zurich, Switzerland-based Nanoflex designed its robotic system with a compact magnetic field generator and a navigation control unit. These […]
Natus Neuro taps Philips, Medtronic veteran as CEO
Natus Medical (Middleton, Wisconsin) recently announced that a well-known executive in the Minneapolis-St. Paul medical device hub is the new CEO of its Natus Neuro business. Chris Landon joined Natus last month after serving for four years as the president and GM of Image Guided Therapy Devices at Philips. Before Philips, Landon worked at Medtronic […]
Report: Pharyngeal neurostim company Phagenesis raises $42M
Axios reports that British medtech company Phagenesis confirmed that it raised $42 million in a Series D financing round. The outlet says CEO Reinhard Krickl confirmed the Manchester, U.K.–based company’s latest funding. According to the report, EQT Life Sciences and Sectoral led the round, with new investors British Parent Capital, Northern Gritstone and Aphelion joining […]
Medtronic wins FDA clearance for bone tumor ablation tech
Medtronic announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system. The medtech giant designed OsteoCool 2.0 to treat painful bone metastases and benign bone tumors like osteoid osteoma. The minimally invasive procedure uses probes to deliver radiofrequency energy that heats and destroys tumors. Meanwhile, it circulates water to […]
Philips, SyntheticMR partner on AI-based brain imaging
Philips announced today that it launched its Smart Quant Neuro 3D for brain disorder diagnosis and therapy. The company unveiled the system at ECR2024 in partnership with Swedish MRI software solutions company SyntheticMR. Smart Quant Neuro 3D provides objective decision support for disorders like multiple sclerosis (MS), traumatic brain injury (TBI), and dementia. According to […]