SetPoint Medical announced today that the FDA accepted it into the Total Product Life Cycle Advisory Program (TAP) pilot. TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. Acceptance requires breakthrough device designation, which SetPoint Medical garnered last week. With […]
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.
🧠 Narrow your focus with these categories:
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
Onward raises $22M to support neurostim tech
Onward Medical announced today that it successfully raised $21.8 million (€20 million) in gross proceeds through a private placement. The company offered more than 4.4 million new ordinary shares at an issue price of $4.89 (€4.50) per share. It completed the offering with participation from institutional investors, certain founders and management and members of the […]
Neuralink says patient used brain chip to play chess online
Elon Musk’s Neuralink brain-computer interface (BCI) venture showed the early results from the first patient to receive its brain chip implant. A nine-minute livestream demonstration on Musk’s “X” social media platform (formerly known as Twitter) showed Noland Arbaugh using the Neuralink BCI to move a computer cursor and play chess online. Arbaugh, a quadriplegic, said he […]
LivaNova reports positive study results for neuromod for sleep apnea
LivaNova today announced positive outcomes from a study of its nerve stimulator system for treating sleep apnea. The company said its OSPREY clinical trial achieved a positive predictive outcome and concluded enrollment earlier than anticipated. This means the company projects a greater than 97.5% probability that OSPREY successfully meets its primary endpoint. London-based LivaNova’s OSPREY […]
Axonics wins CE mark for 4th-gen rechargeable sacral neuromod system
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 […]
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 […]