Weekly Signal: 36 | ALS Trials Accelerate, Ultrasound Advances, MRI Goes Bedside

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🧠 Weekly Signal

Neurotechnology News | Nov 29 – Dec 5, 2025

Let's cut through the noise this week!

This week, we saw noninvasive ultrasound modulate deep reward circuits and major regulatory momentum for ALS therapeutics entering Phase 1/2 and Phase 3 testing. Industry deployments extended AI-enhanced portable MRI into critical care workflows. Meanwhile, neurorights debates focused on consent and neural data sensitivity. Bottom line: neurotech is maturing clinically while governance pressures intensify.

🧠 SCIENCE & CLINICAL TRIALS

🟢 Deep-brain ultrasound tunes human reward circuits

Published: November 29, 2025
Read more ➡️ BioRxib / Neuroscience News

A randomized within-subject study in 26 adults used transcranial ultrasound stimulation to target the nucleus accumbens and showed faster learning from rewards, higher “win–stay” behavior, and altered blood-oxygen-level–dependent (BOLD) responses compared with sham and control-site stimulation. The Nature Communications paper reports that brief (≈60 s) ultrasound pulses produced changes comparable to deep brain stimulation while remaining fully noninvasive.

💡 Big Picture: This is one of the clearest demonstrations that focused ultrasound can causally modulate deep human reward circuitry, pointing toward nonimplant neuromodulation strategies for addiction, depression, and other motivation-related disorders.

🟢 FDA clears Phase 3 trial of PrimeC for ALS

Published: December 2, 2025
Read more ➡️ ALS News Today / PR Newswire

The FDA authorized a pivotal Phase 3 trial evaluating PrimeC, an oral combination of ciprofloxacin and celecoxib that slowed ALS progression by 37% in a Phase 2b study. The trial will assess functional decline, biomarkers, and survival across a large, multisite patient population.

💡 Big Picture: This is one of the few late-stage ALS candidates targeting neuroinflammation and RNA dysregulation, addressing a space where approved therapies provide limited benefit.

🟢 FDA clears first-in-human trial of VTx-002 targeting TDP-43 pathology

Published: December 3, 2025
Read more ➡️ PharmaPhorum / businesswire

VectorY received FDA IND clearance to begin human testing of VTx-002, the first clinical program designed to selectively clear toxic TDP-43 protein aggregates found in up to 97% of ALS cases. The Phase 1/2 trial will assess safety, target engagement, and pharmacodynamics of the vectorized antibody approach.

💡 Big Picture: Targeting TDP-43 directly represents a mechanistic shift toward treating ALS at its molecular origin rather than managing downstream neurodegenerative consequences.

💼 INDUSTRY & STARTUPS

🟢 Hyperfine’s AI-powered portable MRI reaches ICU bedside

Published: December 3, 2025
Read more ➡️ wrnj radio / Atlantic Health

Atlantic Health’s Morristown Medical Center has deployed Hyperfine’s next-generation Swoop® portable brain MRI with Optive AI™ software in its intensive care units and emergency departments, allowing diagnostic-quality neuroimaging without transporting critically ill patients. The system is engineered for higher signal-to-noise ratio, improved resolution and uniformity, and faster acquisition times, and is already being used for stroke, brain tumors, and head injury cases.

💡 Big Picture: Bedside, AI-enhanced MRI shifts neuroimaging from fixed scanners to point-of-care workflows, potentially redefining how hospitals triage and manage acute neurological emergencies.

🟢 Hoffman ALS Awards fund two emerging genetic therapies

Published: December 4, 2025
Read more ➡️ ALS Association

The ALS Association awarded $1.5 million to advance antisense oligonucleotide and gene therapy programs targeting ALS-related mutations, supporting IND-enabling studies and manufacturing readiness. These funds bridge a critical financing gap that often prevents early-stage neurogenetic candidates from reaching human trials.

💡 Big Picture: Strategic preclinical funding accelerates the ALS drug pipeline and increases the likelihood that genetically targeted therapies reach first-in-human evaluation.

🏛️ POLICY & ETHICS

🟢 Brain data as a human-rights frontier (In case you’ve missed it)

Published: December 3, 2025
Read more ➡️ Times of India / UNESCO

A legal-focused column argues that neural data from consumer and medical neurotechnology should be treated as a distinct, highly sensitive category, emphasizing explicit consent, limits on secondary use, and protections against inference-based discrimination. It situates these concerns within UNESCO’s newly adopted global ethical standard, which recognizes “neural data” and stresses mental privacy, cognitive liberty, and bans on certain non-therapeutic uses, especially in children.

💡 Big Picture: With a UN-level framework now in place, national regulators and companies face growing pressure to treat brain data less like general biometrics and more like a protected dimension of personhood.

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