News
FDA and CMS Try Again: Can Coverage Catch Up?
For neurotechnology companies, FDA authorization is only one step toward commercial adoption. Medicare coverage and adequate payment remain separate hurdles. Two federal initiatives address different parts of that challenge: CMS’s proposed Regulatory Alignment for Predictable and Immediate Device coverage pathway, or RAPID, would bring coverage considerations into clinical development earlier, while the NOPAIN Act provides temporary additional payments for qualifying non-opioid pain treatments. RAPID is a proposed administrative pathway; NOPAIN is enacted legislation. Together, they illustrate both the opportunities and the remaining gaps in translating regulatory success into patient access.
Briefings: Science Corp’s PRIMA Data, Bridge Neurotech Taps Butterfly for BCI, Beacon Biosignals Partners with Project Sleep, NeuWire’s FDA Win for Stroke Study
Ceribell gains FDA clearance for quantitative EEG trending software; Epiminder enrolls 100th patient in DETECT epilepsy study; Fareon publishes Long COVID trial results for its at-home magnetic therapy headset; Lund University begins clinical testing of High Definition Brain Stimulation electrodes; an injectable, easy-to-remove helical wire electrode drives tibial nerve stimulation through the skin in pigs; Firefly partners with NeuroSigma on pediatric ADHD treatment access; Phosphoenix raises €1.3 million for visual neuroprosthetic; and more.
Neurotech Reports Announces Allan May and Walter Greenleaf, PhD, as Keynote Speakers for the 25th Anniversary Neurotech Leaders Forum
Neurotech Reports announced that Allan May, Co-Founder and Chairman of the Board at Life Science Angels, and Walter Greenleaf, PhD, Neuroscientist, Virtual Reality, and Digital Health Expert at Stanford University’s Virtual Human Interaction Lab, will keynote its 25th Anniversary Neurotech Leaders Forum.
CMS’ Shift from TPT to RAPID Will Transform Bioelectronic Medicine Device Reimbursement
The journey to securing reimbursement for a new medical device involves three critical steps: obtaining a CMS code, securing Medicare coverage (via national and local coverage determinations, and Medicare administrative contractors), and establishing payment levels. During the first step, securing a permanent CMS and HCPCS reimbursement code is a multi-year endeavor. To provide reimbursement during these early years, CMS issues temporary “C-codes” for some medical devices soon after FDA Premarket Approval. Valid for two to three years, these C-codes enable devices to receive transitional pass-through payments at both hospitals and ambulatory surgical centers.
Neurotech’s FSA/HSA Playbook Runs Through Four Systems
FSAs and HSAs hold tax advantaged money that never touches a payer contract nor a CPT code. Reaching these funds means choosing among a retail list, a clinician’s letter, an FDA pathway, and a reimbursement form, each with a different tradeoff on what a neurotech company can claim.
VNS Study Points to Vascular Mechanism Behind Durable Learning Effects
Vagus nerve stimulation, long heralded as a neuromodulatory technology acting through autonomic nerve connections, may also work by tuning the physical behavior of blood vessels in the brain. A new mouse study from researchers at Tohoku University adds weight to the view that the autonomic interface between body and brain can shape learning by altering vascular dynamics after training.
Journal Article Recaps Impact of SPARC Program on Bioelectronic Medicine
A newly published article in the journal Bioelectronic Medicine, authored by several pioneers in the field, outlines many of the achievements produced by the NIS’s SPARC program, which ended in 2025. The SPARC program—Stimulating Peripheral Activity to Relieve Conditions—was launched in 2015 with a practical and ambitious premise: bioelectronic medicine would not scale clinically unless the field first built a shared precompetitive foundation for understanding, accessing, stimulating, recording, and modeling the peripheral nervous system.
Arbor Neuroscience Emerges to Map Brain Circuits Targeted by Neuromodulation
Philip Sabes, CEO of Arbor Neuroscience and cofounder of Neuralink, suggests in a recent company blog post that we are taking the same, woefully inadequate approach to treatment. “A diagnosis is a category, agreed on by convention. Symptoms are what a particular person actually experiences,” he noted. “Two people with the same diagnosis can look very different.”
Mobia Medical: from Application Evolution to IPO to Commercialization
Formerly known as MicroTransponder, Austin, TX-based Mobia Medical is commercializing Vivistim, an implanted vagus nerve stimulation system indicated for use during rehabilitation therapy to reduce upper-extremity motor deficits and improve motor function in chronic ischemic stroke patients with moderate to severe arm impairment.
MIT Microscope Offers a Faster Look at Whole-Brain Electrical Activity
A new high-speed microscope from MIT could give neuroscientists a more direct way to observe how neurons communicate across an entire brain—an advance with implications for basic neuroscience, neurotechnology tool development, and future efforts to map distributed neural circuits in real time.
