On the Reg: The Next 50 Years of Med Device Markets
Issue 02: CMS Limits, Biohybrid BCI Timelines, In-Home Devices, & More
On the Reg is a new initiative to spotlight strategy, opinion, and insights from the neurotech field’s evolving regulatory landscape. It’s written for and by commercial leaders and experts from our audience of engaged readers.
Table of Contents - May 2026
A 50 Year Outlook
Regulatory Lessons from the Move to At-Home Use for Spinal Neurostimulation
Short-Term & Long Term: Regulatory Pathways & New Tech Access
Is CMS Killing Breakthrough MedTech? A View from the Other Side
CDRH’s READI-Home Innovation Challenge Announced
Regulatory Futures: How long does it take to bring a next-gen interface to market?
Crucial Context for HHS Secretary Kennedy’s Anti-Antidepressant Push”
FDA’s Guidance on Content of Human Factors Information in Medical Device Marketing Submissions
Thank you to our guest contributors and featured experts in this edition! Omari Bouknight from Resonant Link Medical & Nada Hanafi from MedTech Strategy Advisors, Susan Lubejko and Abby Copeland at Mittal Consulting, Blythe Karow at The Device Files, Jennifer Newberger and colleagues at the FDA Law Blog, Juan Benet from Protocol Labs & Max Hodak from Science Corp, Dr. Owen Muir from the Frontier Psychiatrists.
The Next 50 Years and the Next 50 Days
By Naveen Rao
Yesterday marked 50 years since the passage of the Medical Device Amendments of 1976, which created today’s “modern” risk-based framework for US medtech regulation. That makes today the first day of the next 50 years of FDA-regulated neurotech markets.
With SO many changes afoot and ahead at the FDA, it is a perfect time to call for bold thinking about the myriad opportunities to evolve regulation of neurotech devices meaningfully, systematically, and proactively. The last few weeks of federal activity offer policy mavens some ideas for how to manifest alternative futures for neurotech markets.
An April 18 Executive Order directed the FDA to issue priority vouchers for three companies developing psychedelic medicines for serious mental illness, plus an investigational clinical study by a fourth. The XO also commits $50m from ARPA-H to match state-level research efforts. This story is still evolving, but it’s turned a new chapter. Who in the neuromod industry will advance similar playbooks for bold policy action? Today’s momentum around fast-acting TMS, focused ultrasound, and even certain implanted neurostimulators are worth following closely.
On April 23, CMS & FDA announced the RAPID program, about a week after CMS proposed repealing NTAP. Is the new pathway (the third such attempt this decade) another narrow stopgap? Who will advance more systemic payment fixes to support competitive industry segments and prioritize fixes to accelerate innovation for patients while maintaining clinical rigor?
On April 28, The FDA announced a Real-Time clinical Trials Initiative for drugs. The agency has extended the comment period until July 29th. Will any device manufacturers seek inclusion in this new project, either for biomarker R&D, neuromonitoring, or long-term clinical studies for novel medical devices?
On May 12, the FDA Commissioner Marty Makary resigned, casting doubt over the modernization efforts he began. This triggered another wave of departures, including both veteran leaders at the agency and new appointments, such as the agency’s first ever AI Head after only months on the job. Advocacy groups have been trotting out names, but the agency’s challenges are compounding. Despite the well-documented challenges and outflux of neurotech regulatory experts to industry, CDRH has benefited greatly under Michelle Tarver’s steady leadership.
Over the next 50 years, what major policy reforms to medical device development will be remembered? Who is working on this in the next 50 days? The 50 days after that?
Short-Term & Long Term: Regulatory Pathways & New Tech Access
In Resonant Link Medical’s recent episode of Powering the Future Within, CEO Omari Bouknight sat down with Nada Hanafi, founder of MedTech Strategy Advisors, for a discussion about regulatory strategy, product development and long-term change at the FDA. Some highlights:
On FDA BDD and initial submission strategy: “You shouldn’t tie your business strategy to your regulatory strategy. And vice versa. You should have a business strategy and a goal. Have your aspirational claims, whatever north star you’re shooting to and you should develop a regulatory strategy to support that….but don’t promise the world and not deliver on the minimum. It’s a stepwise approach: What we’re trying to tee up is a reasonable pathway to get you there because your aspirational claims may require extensive amounts of evidence, and you need to show some proof points of success. I’m not saying don’t think of the future…but if there is a narrower or more focused or more imminent patient population that can benefit, then let’s start there.”
On Postmarket Surveillance: “It seems as though FDA has become more and more interested and willing and open to postmarket surveillance in a clinically driven way. Meaning that perhaps your follow-up period might be one or two years and you’re able to show a nice signal of safety and effectiveness and then FDA will say, ‘Well, this is a very innovative technology. We think that you’re starting to show benefit versus risk. We’ll let you on the market. we’ll prove the device and then we’re going to surveil you in a very clinically driven way going forward.’ So, it seems like that postmarket aspect will be more and more important and something that the agency is more and more interested in exploring.”
On the next generation of FDA Leaders: “If we have more leadership that’s representative not just from a gender/sex perspective but from a race/ ethnicity, and I’m also a big believer on the age piece. Even seeing the political leadership in New York now I am so excited. So I think you need to have all all voices at the table in that sense…And having that ultimately, hopefully leads to access and better products.”
Is CMS Killing Breakthrough MedTech? A View from the Other Side
Blythe Karow, Founder & Principal, Karow Advisory Group, and Editor, The Device Files, published a a three-part interview series with Dr. Lee “No Video Games” Fleisher, the former Chief Medical Officer of CMS.
Part One: Congressional action on “Benefit Category” could be a fulcrum for more systemic coverage reform across CMS. “So when CMS says it cannot cover something, sometimes what they mean is “we evaluated it and decided it isn’t reasonable and necessary,” which is a judgment call within their authority. And sometimes what they mean is “this isn’t a benefit category at all, we have no legal authority to pay for it regardless of how good it is.” Those are very different statements, but they are often voiced with the same shrug. So, according to Lee, the law was structurally flawed in part because it did not address benefit categories. It said, in effect, pay for things that in a lot of cases Congress had not authorized CMS to pay for.”
Part Two - 2024 TCET program’s constraints limited the focus on PMA: An anonymous CMS source says that “TCET was scoped and implemented by CMS specifically for Pre-Market Approval (PMA) class devices by design.” Lee was at CMS during publication of the TCET pathway and knew that resources would be limited to five or so approvals a year, but the implementation of TCET was after Lee’s departure from CMS. Evidently the decision was made after his time that - because…the entire CMS coverage group has 35 to 37 people, in his estimate, possibly fewer now after departures earlier in the year. They are responsible for novel coverage decisions across a Medicare program that handles close to a trillion dollars in spending annually. As Director of CCSQ, Lee oversaw a $1.7 billion budget but couldn’t just shift $10 million from one program into the coverage group. The structure of CMS appropriations does not permit that kind of internal reallocation. Expanding the coverage group requires an act of Congress.”
Part 3: CMS’ thinking behind NTAP’s demise, RAPID’s emergence, and more: “Lee’s explanation of what CMS is saying with this move came down to one word the CMS political leadership keeps using in his meetings: deinflationary. The argument from CMS is that too many devices that took the alternative pathway have not, in retrospect, demonstrated substantial clinical improvement over what was already available. CMS is no longer willing to take breakthrough designation as a proxy for the substantial clinical improvement criterion. Companies will have to show their work.”
Regulatory Lessons from the Move to At-Home Use for Spinal Neurostimulation
By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting
The past two years have been prolific for non-invasive transcutaneous spinal stimulation. Onward Medical’s pioneering ARC EX System De Novo (DEN240014) was first cleared in 2024 for clinic use. This non-invasive technology is intended for improvement of hand sensation and strength in spinal cord injury patients when used in conjunction with functional tasks (i.e. daily living activities).
Since then, three 510(k) clearances have used this De Novo to enter the space:
Onward Medical’s follow-up ARC EX System submission (K251821, November 2025),
ANEUVO’s ExaStim Stimulation System (K252893, March 2026), and
Spinex’s xStep (K253638, April 2026).
The ARC EX and ExaStim 510(k) clearances stand out as they both move the technology from clinic only use (the original De Novo indication) to at-home use. ARC EX and ExaStim’s expanded use environment strategies are in alignment with a 2- step 510(k) approach that is expected for most novel devices to gain at-home use indications.
The first 510(k), or De Novo in Onward Medical’s case, pursued an in-clinic use indication, followed by a subsequent 510(k) for at-home use. This typical trajectory allows for manufacturers to collect data on novel devices in the controlled clinical environment and subsequently run additional studies to convince FDA that untrained users can safely use a device, follow the instructions, and effectively handle any glitches without major risk. ExaStim also followed the same pattern of using ONWARD Medical’s De Novo to prove the safety of in-clinic use and a 510(k) to gain at-home indications. Because the ARC EX 510(k) had not yet been cleared before ExaStim’s submission date, both manufacturers needed to independently provide data and rationale to support a use environment change from the same in-clinic De Novo.
While these clearances above follow a predictable 2-step pattern, what is interesting about them is the evidentiary burden required to support the 510(k)s. Review of the two 510(k) summaries reveals a relaxation in FDA’s usual expectations for use environment change by requiring relatively less additional validation data than has been necessary for past devices. Both devices likely benefited from ARC EX generating data on safety and user experience in clinical use. In addition to typically required testing for a first-time device, ExaStim was able to demonstrate safe at-home use through human factors/usability testing alone. More surprising is FDA’s clearance of ARC EX at-home use with no additional assessments performed, relying entirely on previously submitted De Novo data and the argument that the environment presents a negligible change, whereas usability testing is the norm for making this shift. This potentially signals that in the neuro space, FDA is becoming more comfortable with reducing evidentiary burden to segue to at-home use.
These case studies help inform future FDA interaction strategy about use environment shifts in the neuro space. Manufacturers making this transition should consider taking bolder steps to negotiate with reviewers on small, well-designed studies that can support this new indicated use without undue validation burden.
CDRH’s READI-Home Innovation Challenge Announced
By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting
In April 2026, FDA announced the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation challenge. The purpose of the READI-Home Challenge is to support manufacturers working on at-home devices that could appreciably decrease hospital readmissions. This is important because devices intended for home use face unique challenges due to the fundamental differences between the home and clinic. Device usability by patients and caregivers, instructions for use, and environmental risks must be considered during device design, validation, and premarket submission.
To understand where READI-Home fits into FDA’s overall strategy for at-home devices, let’s look at CDRH’s historical efforts in this space. Driven by public request for guidance on demonstrating safety and effectiveness of home-use devices, in 2024 CDRH began to address this concern by establishing the Home as a Healthcare Hub Initiative. Home as a Healthcare Hub is composed of an online Idea Lab which is currently exclusively focused on patients with diabetes. It is an online resource designed to show manufacturers the real-world challenges patients face using fictional personas and virtual reality software that simulates their at-home lives.
While Home as a Healthcare Hub provides awareness and conceptualization support, it does not provide incentives or direct FDA regulatory support for premarket acceleration of these devices. Therefore, the READI-Home program was created to fill this gap in the original program. In this new READI-Home program, FDA is recruiting a total of nine (9) devices from distinct manufacturers that meet the following criteria: 1) should address an unmet health care need in the home, 2) be intended for use by the patient or caregiver at home, and 3) demonstrate feasibility to reduce hospital readmissions.
Selected participants will have the opportunity to engage in Sprint discussions (accelerated FDA discussions which are already a standard option for Breakthrough Devices) to refine device design and testing and can also live-demo their technology in-person at FDA research facilities. Because this is a new program beginning its first interaction phase in December, specific details will likely be forthcoming; however, if FDA follows the same format for Breakthrough sprint discussions, these may consist of single-topic negotiations with FDA reviewers on a predetermined timeline. This would vastly decrease the time to FDA feedback compared to standard premarket avenues and, ideally, the time to market for selected devices.
Until the interaction phase of READI-Home begins, questions remain regarding the potential success of the increased FDA interaction, but the possible upside is high for novel device manufacturers looking to accelerate time through the premarket phase. If you are a device manufacturer developing premarket at-home devices with promise to reduce hospital readmission, make sure to apply to READI-Home challenge using the Q-Submission process by September 30 to be considered.
Regulatory Futures: How long does it take to bring a next-gen interface to market?
On Juan Benet’s inaugural podcast episode, Max Hodak anticipated the path to bring a biohybrid BCI into the commercial market through the FDA. He has also spoken about leveraging AI internally to accelerate regulatory requirements.
“It usually takes at least three to four years to get through a clinical trial for something like this. You’ll spend a year kind of getting set up. You’ll write your protocol. You’ll get IRB approval. You’ll go through you’ll get all your documentation. That takes like at least a year. And then you’ll enroll your participants. That can take a while. And then you’ll have to follow them for at least 12 months. There’s no way that the FDA is even going to look at your data for less than 12 months. And they’ll probably want two and three year follow-ups. But you can kind of do that as you go.
And so if you got a two-year endpoint and they really want to see a third year follow-up, then you have like a year of setup, you have a year where you’re kind of implanting people and then you’ll start getting people hitting the 12-month check and 24-month checkpoints at some rolling window after that.
Once you’ve got a suitable number of patients out to two years, that’s probably enough to start thinking about submitting a larger filing to the FDA. And then while you’re going through that process and they’re reviewing it, you’ll start to get your 36-month data in and they’ll they’ll look at that as it comes in. And then after that, you can imagine another year to get an approval and get on market. So that’s at least a a four or so year process. Plus the sub, five years that you mentioned. Within 10 years this could be on market.”
As the next wave of high-risk, high conviction bets in brain health emerges, how could regulatory science change with the times, not for cutting corners or skipping steps, but for accelerating clinical discovery and time to impact?Listen to the whole episode to learn more about Science’s business model and regulatory strategies.
Crucial Context for HHS Secretary Kennedy’s Anti-Antidepressant Push
This is is excerpted from Dr. Owen Muir’s tremendous substack, The Frontier Psychiatrists, where this originally appeared in response to the HHS Secretary’s recent “push to help Americans quit antidepressants.”
“What was missing, for me, from both Kennedy’s plan—emphasizing only nutrition, exercise, and other demonstrably beneficial lifestyle interventions—was any mention of other effective biological treatments that don’t have the same risk profile…. But nobody mentioned what the other interventions might be!
It’s Brain Stimulation. Brain stimulation exists! In various forms, it is FDA-cleared and FDA-approved already. In-home and in clinic! It involves treatments like ProlivRx, the Flow Device, transcranial magnetic stimulation, and deep brain stimulation, covered ad infinitum in this very newsletter. It also includes accelerated forms of treatment like SWIFT, SAINT, and investigational One-D. It even involves self-neuromodulation using EEG-fMRI biomarkers, like Prism.
There are even entire companies, such as Salma Health, my company, Radial, Beckley Clinical, and Mindful Health Solutions, that provide such treatments. If only there were an organization that could help set priorities for these non-pharmaceutical treatments for depression? You know something like a department, for health, or humans, or services, that included a massive national mechanism to determine how things might be paid for under either Medicare or Medicaid?
Oh, wait, CMS exists too! They can make a call to action! In fact, they’re just calling themselves with a call to action. They can just “to action!”
What “action” you ask? Remove prior authorization requirements for transcranial magnetic stimulation and other breakthrough neuromodulation treatments. Cover these things under Medicare, don’t require prior medication trials, because that means more antidepressant prescribing, which the evidence shows is dangerous for some people.
Regulate health insurance payors similarly. When payors have policies that require patients to go back to drugs to get brain stimulation… maybe HHS could look at the above evidence. They could say: “That’s not something health insurance companies in America are allowed to do anymore.”
There are several steps CMS could take tomorrow. Unfortunately, they weren’t mentioned in the article or in Robert Kennedy’s announcement, and this seems like a miss to me. I humbly submit that if HHS covers brain stimulation treatment more broadly than it does medications, the problem will resolve more quickly. Now, where are the steps off this soapbox so I don’t trip and fall on my face?”
Content of Human Factors Information in Medical Device Marketing Submissions
As summarized by RAPS, “The US Food and Drug Administration (FDA) has finalized a revised draft guidance from 2022 on what human factors (HF) information sponsors should include in premarket submissions for medical devices. On 28 May, FDA published the final guidance, which includes additional risk-based factors that sponsors should consider when determining the human factors submission category, new examples in the appendices, and clarification about the scope of the guidance. While the guidance applies to marketing submissions for medical devices, including 510(k) premarket notifications, De Novo requests, and premarket approval (PMA) submissions, the final guidance also addresses combination products.”
Check out the upcoming Town Hall on Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance
Date: July 22, 2026
Time: 1:00 – 2:00 p.m. ET
That’s a wrap!
Thanks again to our contributors for helping launch this inaugural edition.
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