The FDA today issued a draft guidance with recommendations for clinical trials for certain devices intended for treating diabetes. Included in the guidance are recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus, independent of medication delivery, according to […]
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
Is renal denervation back as a high blood pressure treatment?
Medtronic (NYSE:MDT) today reported clinically significant and sustained blood pressure reduction among nearly 3,000 people with uncontrolled hypertension treated with the company’s Symplicity renal denervation system. The study results, reported today out of the 2021 EuroPCR Annual Meeting, come the same week as ReCor Medical touted its own positive renal denervation study at the American […]
Axonics closes $201.3M offering
Axonics (NSDQ:AXNX) announced today that it closed a public offering of common stock worth proceeds of more than $200 million. Irvine, Calif.-based Axonics, which develops the Axonics r-SNM (sacral neuromodulation) system to treat bladder and bowel dysfunction, offered more than 4 million shares of its common stock at $50 per share, according to a news […]
Axonics announces $150M offering
Axonics (NSDQ:AXNX) announced today that it commenced a proposed public offering of common stock worth $150 million. Irvine, Calif.-based Axonics, which develops the Axonics r-SNM (sacral neuromodulation) system to treat bladder and bowel dysfunction, also expects to grant underwriters a 30-day option to purchase up to $22.5 million in additional shares of its common stock, […]
Neuroelectrics raises $17.5M Series A
Brain stimulation technology developer Neuroelectrics announced today that it raised $17.5 million in a Series A financing. Morningside Ventures led the funding round, the proceeds for which are earmarked for the development of Neuroelectrics’ non-invasive transcranial electrical stimulation (tES) platform. Cambridge, Mass./Barcelona, Spain-based Neuroelectrics plans to use funds to advance clinical trials for the platform […]
Spine surgeon settles with DOJ for $4.4M in whistleblower case
The U.S. Department of Justice today announced a $4.4 million settlement with spine surgeon Wilson Asfora in a whistleblower case. According to a news release from the Joseph Greenwald & Laake law firm, which represented the whistleblowers, Asfora settled for the $4.4 million sum and a six-year exclusion from all federal payer programs, effectively precluding […]
Bexson Biomedical wins U.S. patent for ketamine formulation
Bexson Biomedical announced that the U.S. Patent and Trademark Office (USPTO) granted a patent for its BB106 ketamine therapy. Santa Barbara, Calif.–based Bexson’s patent describes pharmaceutical formulations and treatment methods for the ketamine therapy, which the company believes allows for safety, comfort and pharmacokinetics that improve the administration of ketamine through multiple avenues, including the […]
LivaNova rises on Street-beating Q1
LivaNova (NSDQ:LIVN) shares got a boost this morning on first-quarter results that beat the consensus forecast. LIVN shares were up 6.1% at $87.95 per share in early-morning trading today. The London-based company posted losses of -$29.7 million, or -61¢ per share, on sales of $247.6 million for the three months ended March 31, 2021, for […]
Medtronic partners with Surgical Theater to bring augmented reality to neurosurgery
Medtronic (NYSE:MDT) announced today that it partnered with Surgical Theater to offer an augmented reality platform for cranial procedures. Fridley, Minn.-based Medtronic will interface its StealthStation S8 surgical navigation system with Surgical Theater’s SyncAR technology to enable neurosurgeons to use AR in real-time to enhance their visualization during complex cranial procedures, according to a news […]
Neurolutions wins authorization for stroke rehab device
The FDA announced today that it authorized the Neurolutions IpsiHand upper extremity rehabilitation system for stroke rehab. De novo authorization encompasses patients 18 years of age and older who are undergoing stroke rehabilitation to facilitate muscle re-education and need to maintain or increase their range of motion, according to a news release. It is a […]
NeuroPace shares take off on first day of trading
Epilepsy treatment developer NeuroPace (NSDQ:NPCE) shares skyrocketed today during its first day of trading on the Nasdaq market. Mountain View, Calif.-based NeuroPace shares were trading up 37.4% at $23.35 per share in mid-afternoon trading today. The company announced last month that it filed with the SEC to raise up to $75 million in an initial […]