The FDA confirmed that a recall of cranial software from Medtronic (NYSE:MDT) has been designated as Class I, the most serious kind of recall. Both the Synergy Cranial and StealthStation S7 Cranial software are included in the recall, which affects 943 devices distributed between May 1, 2019, and Oct. 29, 2021, in the U.S. Medtronic […]
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
FDA advisory votes against BrainsGate’s neurostim device for treating stroke
At the end of last week, an FDA advisory panel voted down BrainsGate’s neurostimulation device for treating stroke. BrainsGate designed its technology as a five-minute procedure. A neurostimulator implant is injected into an existing canal to stimulate a nerve center and augment collateral blood flow, improving stroke patients’ outcomes within a 24-hour window. The platform […]
CereVasc successfully performs first-in-human procedure with eShunt system
CereVasc announced today that it completed the first treatment with its eShunt system for treating communicating hydrocephalus (CH). Boston-based CereVasc touts the eShunt as the first minimally invasive cerebrospinal fluid shunt and delivery technology designed to avoid the need for invasive surgery and extended hospitalization associated with the current surgical treatment of hydrocephalus. The company […]
Medtronic posts Q2 EPS beat, misses on revenues as U.S. sales dip
Medtronic (NYSE:MDT) shares are down this morning on second-quarter results that missed the consensus revenue forecast. MDT shares were down 0.4% at $116.40 per share before the market opened today. Shares have since dipped down 2.5% at $113.93 per share after the market opened. The Fridley, Minnesota-based medtech giant posted profits of $1.3 billion, or […]
FDA grants breakthrough nod to Pear Therapeutics’ alcohol use disorder treatment platform
Pear Therapeutics announced today that it received FDA breakthrough device designation for its reSET-A prescription digital therapeutic. Boston-based Pear Therapeutics designed its reSET-A PDT product candidate for treating alcohol use disorder (AUD), adding to the company’s portfolio of PDTs for treating substance use disorder (SUD) and opioid use disorder (OUD). The breakthrough device designation granted […]
Better Therapeutics completes enrollment in type 2 diabetes study
Better Therapeutics (NSDQ:BTTX) announced that it completed patient enrollment in a study of its digital therapeutic in treating diabetes. San Francisco–based Better Therapeutics’ BT-001 prescription digital therapeutic delivers a novel form of cognitive-behavioral therapy to patients with uncontrolled type 2 diabetes. Get the full story at our sister site, Drug Delivery Business News.
FDA gives Bexson pre-IND guidance for ketamine formulation delivered by wearable pump
Bexson Biomedical announced today that it received pre-investigational new drug guidance from the FDA for its ketamine compound therapy. Santa Barbara, California-based Bexson develops the patented BB106 formulation, a ketamine therapy delivered through a wearable, subcutaneous patch pump in development with Stevanato Group. Get the full story at our sister site, Drug Delivery Business News.
FDA grants breakthrough nod to Blackrock Neurotech’s brain-computer interface
Blackrock Neurotech announced that it received FDA breakthrough device designation for its MoveAgain brain-computer interface (BCI) system. Salt Lake City-based Blackrock Neurotech designed its MoveAgain BCI system to provide immobile patients the ability to control a mouse cursor, keyboard, mobile device/tablet, wheelchair or prosthetic device by only thinking, according to a news release. The company […]
Pear Therapeutics picks up another $50M ahead of going public through SPAC merger
Pear Therapeutics and Thimble Point Acquisition Corp. announced today that they received additional funding worth $50 million ahead of a merger. Boston-based Pear Therapeutics confirmed in June that it will go public by merging Thimble Point Acquisition Corp., a special purpose acquisition company (SPAC). A special meeting will be held for Thimble Point stockholders to […]
Time recognizes Abbott offerings among this year’s 100 best inventions
Abbott (NYSE:ABT) was among a series of medtech companies to receive recognition from Time in its list of 2021’s best inventions. The list of the year’s top inventions included Abbott’s innovations twice, with a nod to its NeuroSphere Virtual Clinic and its at-home COVID-19 testing offerings. Get the full story at our sister site, Medical Design & Outsourcing.
FDA clears Magstim advanced transcranial magnetic stimulation platform
Magstim announced today that it received FDA 510(k) clearance for its Horizon 3.0 transcranial magnetic stimulation platform. Horizon 3.0 offers enhanced workflows with navigated transcranial magnetic stimulation (TMS) and analytics for the clinical setting, offering connected care at networked sites, according to a news release. TMS, a form of non-invasive brain stimulation, uses an electromagnetic […]