Neurology

Marabio Systems says the new funding will help accelerate efforts to bring a blood test to market in 2025 that will accurately determine if a mother is a carrier of antibodies that cause MARA, a subtype of autism that believe to cause more severe behavior.

The Octane Medical Innovation Forum brought together industry experts, entrepreneurs and investors to discuss a range of topics. Medtech Insight was on the ground to bring some memorable perspectives from industry leaders.

Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

Spain-based Inbrain Neuroelectronics plans first-in-human study to show safety of its graphene-based technology in direct contact with human brain while also developing a second interface for treating Parkinson’s disease.

After announcing positive results showing that its Stentrode BCI is safe in six patients, brain-computer interface company Synchron is planning a pivotal trial to eventually file for FDA approval.

An additional $50m brings the neurovascular intervention specialist’s total Series F funding to $82m. Route 92 says it will use the capital to build its sales and support teams and pursue regulatory authorizations around the globe for its FreeClimb portfolio while advancing its SUMMIT MAX clinical trial for the investigational Monopoint Reperfusion System.

Altoida CEO Mark Jones has high hopes that the company’s digital assessment tool will be approved by the FDA to be used along with blood biomarker testing by primary care doctors to help predict Alzheimer’s disease before patients show symptoms.

Altoida CEO Marc Jones spoke with Medtech Insight about the company’s investigational digital screening tool for Alzheimer’s and the dire need for better, more accessible precision neurology diagnostics as the global population ages, neurologist shortages worsen, and groundbreaking Alzheimer’s drugs change the treatment paradigm.

The companies intend to co-market Siemens Healthineers’ Multitom Rax as part of Medtronic’s AiBLE ecosystem, which combines advanced technologies in navigation, robotics, imaging, data analytics, and AI to enhance the precision and predictability of spine and cranial surgeries.

Click Therapeutics reports positive Phase 3 clinical data for CT-132, a digital therapeutic intended as an adjunctive treatment of episodic migraine. The company is pursuing FDA clearance and actively exploring opportunities to offer a drug-digital combination therapy with added clinical benefit that provides “a single, integrated experience for the patient, prescriber and payer.”

Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston. 

The DBS trial will look at the use of neurostimulation in people with treatment-resistant depression, which affects about 2.8 million Americans each year. The implanted device may relieve depression symptoms by changing activity patterns in the brain.

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.

The devices include a digital therapeutic to treat ADHD and a tongue muscle stimulator to prevent sleep apnea and snoring. They all initially reached market via the de novo process and have now been declared class II.

Caresyntax said it will use the $180m it recently raised in a series C extension and debt financing round to build out its vendor-neutral surgery platform aimed to help surgeons with real-time and long-term decision support to improve patient outcomes and efficiencies.

MindMaze seeks to create a beautiful immersive experience for patients recovering from brain injuries. Chief medical director John Krakauer, clearly a “Star Wars” fan, discusses the significant need for digital therapeutics at a time when therapists are in short supply, as well as the challenges facing the DTx space as a whole.

Medtronic receives US FDA approval for deep brain stimulation surgery for people with Parkinson’s and essential tremors while the patient is under general anesthesia, making it the first and only company to offer DBS surgery while the patient is asleep.

This week, Medtronic recalled a nerve monitoring system due to reports of false responses. The US FDA approved the first auto-injector for opioid-overdose, made by Purdue Pharma. The agency granted de novo authorization for Labcorp’s PGDx elio plasma focus Dx used by labs for genetic profiling. As of 7 August, 950 AI/ML devices have been approved by the FDA. EKO Health teamed up with LSU to help detect arrhythmias and murmurs in student-athletes.

Unilabs and C2N Diagnostics signed a multi-year agreement that will expand access to C2N’s Alzheimer’s tests in Europe and other countries.