10 MedTech Moments from 2025 that Signal a Bright 2026
In 2025, active implantables crossed a meaningful threshold. Across neuromodulation, cardiac rhythm management, sleep apnea, migraine, bioelectronic medicine, brain–computer interfaces, and more, companies didn’t just promise progress — they proved it. FDA approvals, positive randomized clinical trials, first-in-human implants, and major investment announcements all underscore the same shift: active implantables are becoming smaller, more targeted, longer lasting, and more dependent than ever on thoughtful system design.
Here are 10 moments from 2025 that signal what’s to come in 2026.
1. Leadless Cardiac Therapy Reaches a New Standard
When EBR Systems received FDA PMA approval for its WiSE® CRT system, it validated years of work toward eliminating transvenous leads for left ventricular pacing. This milestone underscores a growing industry mandate: deliver therapy without adding hardware burden. Leadless systems raise the bar for power efficiency, telemetry reliability, and long-term energy delivery — especially when implanted in anatomically constrained or dynamic environments.
2. Battery-Free Neurostimulation for Sleep Apnea Gains FDA Validation
The FDA’s approval of Nyxoah’s Genio® system for obstructive sleep apnea reinforced a clear trend: implantable neuromodulation continues to move rapidly into new indications — and rethink traditional battery architectures along the way. For hypoglossal nerve stimulation in particular, the approval also underscores the viability of implantable alternatives to CPAP for obstructive sleep apnea. As stimulation shifts more into autonomic regulation, rechargeability, energy density, and patient interaction with power systems become central design considerations.
3. Bioelectronics Attract Significant Capital
The $140M financing announced by SetPoint Medical was more than a fundraising headline — it was a vote of confidence in chronic, disease-modifying implantable therapies. These therapies aren’t episodic. They demand decades-long reliability, predictable recharge experiences, and system architectures that support evolving therapy parameters over time. For the millions of patients who could benefit from similar therapies, it was exciting to see this market validation of their approach.
4. Electroceuticals Expand Into Functional GI Disorders
When NeurAxis successfully expanded FDA-cleared indications for its PENFS technology into adult functional dyspepsia, it highlighted a growing comfort with neuromodulation for non-structural disease. These patient populations place unique demands on power systems: minimal implant burden, high safety margins, and energy delivery that supports outpatient or pediatric-friendly care pathways. It's a trend we expect to continue.
5. Implantable Migraine Therapy Shows Durable Benefit
Positive 12-month data from ShiraTronics showed that implantable neuromodulation can deliver sustained migraine relief without unanticipated adverse events. As therapies move toward long-term, always-on, and responsive stimulation, power design shifts from “can it work?” to “can it work comfortably, safely, and reliably for years?”
6. Restorative Neurostimulation Seems Here to Stay
Mainstay Medical’s RESTORE trial reinforced a shift toward functional and restorative neuromodulation, where outcomes depend on consistent therapy delivery over long durations. This class of devices places intense focus on total cost of ownership, battery longevity, recharge reliability, and long-term patient adherence — all power-driven variables. From patients to payers, successful device commercialization will increasingly depend on how well these benefits can be quantified and demonstrated.
7. Micro-Implantable Pulse Generators Prove Clinical Value
Data from Nalu Medical’s COMFORT-2 study validated the performance of micro-implantable pulse generators in randomized trials. Miniaturization is no longer optional, and smaller devices magnify the importance of efficient wireless power transfer, thermal management, and charging alignment tolerance.
8. First-in-Human Soft BCIs Enter the Clinic
In a year dominated by BCIs, there have been multiple milestones pointing to the long-term potential of brain-computer interfaces to change how we live. Axoft, as one example, announced completion of the first four cases in its first-in-human clinical study of an ultrasoft, high-density brain–computer interface, designed to improve long-term biocompatibility. Materials science is emerging as a key differentiator in BCIs, with softer, more compliant implants aiming to enable chronic, high-fidelity neural recording.
9. Regulatory Momentum Builds for BCIs
Similarly to the above, this year marked significant progress for other BCI companies. Paradromics received FDA approval to begin early-stage human trials of its Connexus BCI system, marking a key regulatory milestone for the high-data-rate neural interface, and demonstrated their first-in-human capabilities through a partnership with the University of Michigan.
BCIs are transitioning from experimental systems to clinical products, with growing emphasis on safety, scalability, and real-world therapeutic impact. Paradromics’ BCI underscores the importance of advanced data collection and processing capabilities to unlock the full potential of brain-computer interfaces to change patients’ lives.
10. Governments Invest in Enabling Technologies
INBRAIN Neuroelectronics was awarded a €4 million grant under Spain’s PERTE Chip Program to advance development of graphene-based brain–computer interfaces. The award highlights growing public-sector recognition of the importance of medical device components such as next-gen materials and semiconductors to future implant performance, and patient care. While funding shifts globally, this is a key area where investment can accelerate, or limit, innovation. We hope its the former.
Key Takeaways for Implantable Device Development, Commercialization, and Approval
Taken together, these ten milestones make one thing clear: the bar for implantable medical devices has moved. From a development standpoint, teams are being asked to deliver devices that are smaller, more anatomically flexible, more energy-efficient, and capable of supporting chronic therapy over many years. Power can no longer be treated as a late-stage engineering constraint. Instead, it must be considered early — alongside therapy design, form factor, and system architecture — because power decisions increasingly shape what is technically and clinically possible.
From a commercialization perspective, the success of these devices depends not only on clinical efficacy, but on patient experience, physician confidence, and total cost of ownership. Recharge burden, implant longevity, revision rates, and ease of use all influence adoption, reimbursement, and long-term market success. Power architectures that reduce surgical complexity, minimize maintenance, and support predictable long-term performance directly strengthen the commercial case for advanced implantable therapies.
From a regulatory and approval standpoint, the shift toward chronic, disease-modifying, and leadless therapies is driving greater scrutiny of long-term reliability, safety margins, and system-level risk. Regulators are increasingly focused on how implants behave over time — including how they are powered, how energy is transferred, and how failure modes are mitigated. Robust, well-validated power systems can materially de-risk regulatory pathways by supporting safety, consistency, and durability.
Advanced wireless power plays a critical role across all three dimensions. By enabling smaller implants, eliminating physical connectors and leads, supporting intelligent energy management, and improving patient-facing charging experiences, wireless power architectures help device teams align development feasibility, commercial viability, and regulatory confidence.
The breakthroughs of 2025 show that the future of active implantables is not just about better therapy — it’s about better systems. And in these systems, power is no longer invisible. It is a foundational design choice that can accelerate development, smooth approval, and unlock scalable commercialization.
Curious to apply these lessons to your device? Reach out to strategize on the best development and commercialization pathways for you.
