RIVANNA® Co-founder and CEO Will Mauldin, PhD, joined Outcomes Rocket, a healthcare leadership podcast, for a conversation recorded at DeviceTalks Boston, an annual medical device conference. Released June 23, 2026, the episode covers RIVANNA’s clinical platforms and the state of AI in medtech, anchored by a consistent principle: AI delivers the most clinical value when it confirms a clinician’s judgment rather than replacing it.
AI as a confirmation layer, not a replacement
Clinician trust in automated interpretation builds through use rather than instruction. RIVANNA positions its AI as an augmentation to established imaging workflows, not a substitute for clinical judgment. Mauldin describes a clear adoption arc: providers cross-check the AI against the ultrasound image during their first cases, then rely on it more directly after about five to ten procedures as consistent outcomes build confidence.
Bringing imaging to spinal anesthesia guidance
Spinal and epidural anesthesia are often performed without direct imaging of the epidural space, so providers rely on manual landmark palpation. Accuro® 3S addresses that gap. It is a portable, point-of-care ultrasound system built around a proprietary Dual-Array™ convex probe and integrated SpineNav-AI™ image processing software, which overlays automated interpretation onto the familiar ultrasound view. The Dual-Array configuration places two transducer arrays side by side with a narrow opening, enabling an in-line needle approach through the probe’s center. SpineNav-AI identifies key spinal anatomy including the spine midline and indicates the position and depth of the epidural space when detected. RIVANNA announced FDA 510(k) clearance of the Accuro 3S system and its SpineNav-AI software in 2025. On the podcast, Mauldin describes an upcoming needle-tip tracking capability to support live guidance toward the epidural space; this capability is under FDA review and not yet cleared for use.
Easing the radiology bottleneck in musculoskeletal care
The same decision-support architecture applies to musculoskeletal care. Mauldin notes that as many as 20 million patients visit emergency departments and urgent care centers each year with suspected wrist and ankle fractures. In 70 to 80 percent of cases, no fracture is found, yet most patients still undergo radiographic evaluation, sustaining demand on radiology capacity. Accuro® XV received FDA 510(k) clearance in 2026 as a diagnostic ultrasound system that automates large field-of-view B-mode image acquisition without ionizing radiation. Two AI-enabled decision-assist modules are advancing toward FDA clearance: BoneEnhance®, a machine learning software module that segments musculoskeletal anatomy to support 3D visualization of skeletal structures, and CADe/x, a software module that uses machine learning to assist clinicians in detecting fractures from volumetric ultrasound imaging to support triage decisions, including referral for additional radiographic imaging. The CADe/x model is trained on about 1,500 datasets collected across leading academic medical centers.
Automation beneath the AI label
Mauldin describes the engineering directly. RIVANNA’s systems use deep learning and convolutional neural networks trained on large datasets to automate image interpretation that historically required specialist time at the bedside. This capability matters as healthcare demand outpaces the clinical workforce, where point-of-care decision support can reduce bottlenecks and extend specialist capacity.
[00:00:03] Hi everyone, we are here at Device Talks in Boston and we’re excited for another episode, going to bring you the latest and greatest here from the event and the conference. I have Will here, who is the CEO of Rivanna Medical. Really excited to have you here, so thank you so much for joining us. Yeah, thanks for the invitation. Great to be here. Of course, yeah, this is wonderful. So tell us and our audience who’s tuning in, just a little bit about yourself, your company, your background, what do you want the world to know?
[00:00:30] Oh, sure. Yeah, so Will Mauldin, Co-Founder and CEO of Rivanna, and this is a medtech company that I started a number of years ago. And our mission is to innovate in some spaces where imaging technology is not being used to make clinical decisions and to introduce that imaging technology in combination with AI models to automate decisions. So our lead indications and the product that I’ve been working on for a long time is related to epidural anesthesia guidance, epidural spinal anesthesia.
[00:00:59] It’s currently a blind procedure, meaning that the doctor is kind of palpating. And we’ve introduced the first AI-enabled handheld, like, stud finder for the spine product to help guide those. And now we’re introducing our Gen 2, which is going to track the needle for the first time all the way to the epidural space and really improve the safety of these procedures. Wow. We’re also working on an automated fracture detection device. And so it’s a really exciting time for Rivanna. Yeah. We’re based in Charlottesville, Virginia.
[00:01:28] And that’s an exciting time for us. Amazing. You hit the nail on the head there. There’s so much change. There’s so many new innovations happening in the space. And I’m just curious. Talk to us about some of the shifts that you’re seeing. What are you seeing and hearing this year?
[00:01:43] Well, I think maybe the longer-term shifts that I think about related to what we do at Rivanna, related to kind of clinician, growing acceptance around some new technologies that involve AI models and automation and kind of more trust put into those. I think we benefit from being in the imaging space where the vast majority of AI clearances come from radiology and imaging.
[00:02:12] So it’s just a really great fit for that. But also network-connected devices and cloud kind of solutions, taking data and trying to use it. Certainly a trend towards robotics in combination with AI automation. Makes sense. For those who are listening here, there’s actually a bunch of robotics demonstrations here on the floor. So we’ll just talk about that. That made me think of it. Yeah. I’m big on robots, so this has been an exciting surprise for me. Love that. Yeah. To see all the robots. Yeah, they’re more nimble than I.
[00:02:39] I had seen some of the videos online, but I saw some over there imitating a dog, and it really caught white. Like Boston Dynamics. Yeah. Yeah. It makes me really wonder what the future is going to hold for all of us. But I think you brought up such an interesting point. I think I agree. I think AI in diagnostics and imaging was like the first space I saw this green light acceptance of AI in healthcare, along with, of course, administrative tasks and things like that. And, of course, yourself and what your team is bringing to the market adds such value.
[00:03:09] But how are you finding it, carving out that space and bringing your products to the market in an area where everyone’s saying AI, everyone’s talking about what’s your approach there? The anesthesia community is very accustomed to using conventional ultrasound. Yeah. To guide their needles for, like, central line placements, other nerve blockades. So they’re very comfortable with interpreting those images and deciding what to do.
[00:03:35] So the way we’ve introduced our technology initially in our approach is essentially to provide them with those images, but for the epidural space and then allow for an overlay of AI interpretation. And what we see is first few uses, they kind of want to look at the ultrasound image, bring in the AI, compare them. It’s like secondary. Yeah. Secondary confirmation. Yep. They use it. They have successful cases.
[00:04:03] They do that again maybe a couple times and maybe five to ten procedures in, they’re looking at the AI kind of solely. And they’re really trusting that. So that’s been kind of our approach is to position it more as an augmentation. Love that. Than like a replacement. I love that. It reminds me of something else I hear about in this space, but I don’t see activated enough, which is a true clinical decision support layer. Yeah. But not necessarily, like you said, that replacement. It’s not getting in the way.
[00:04:32] It’s a piece that you can gut check. Yeah. The robots are coming, but not yet. Not yet. We’re going to ease them into it. Yeah. Well, anything else wish more people knew about in this space? Any, you know, buzzwords that you’re hearing? Underused? Overused? Well, we’ve been sitting here talking about AI. I mean, that is a little overused. I mean, really, it’s not in AI. I mean, things very broadly. We are implementing like deep learning, convolutional neural network type approaches that are trained on very massive,
[00:05:01] kind of databases. But really, the benefit out of it is just automation. We’re automating the image and interpretation. If you did it with a rules-based technique, you could achieve similar results. It really doesn’t matter that it’s AI in particular. Yeah. Makes sense. It almost sounds like what you’re saying in a way is like this change in terminology. We used to hear the word automation all the time. Now it’s kind of AI, but it is getting at the same core principle, which is ideally to streamline clinicians’ workflows, from what you’re saying. Yeah. Right. Okay. That’s great. Yeah.
[00:05:30] At the core, there is a value and a clinical need to provide decision supports to the clinician, especially as we have more healthcare demand than healthcare workers. And there’s going to be opportunities there. We see it in epidural anesthesia guidance. And also, our other platform is for fracture, bone fracture detection, where there’s like 10, 20 million patients coming in with injured wrists and ankles and clogging our emergency departments, going into urgent cares.
[00:05:57] And there’s a bottleneck associated with radiology and limited radiology workers and rad techs. Yeah. And everybody that has to go essentially determine that it’s not a fracture 70 to 80% of the time. So can we introduce some clinical decision support and triage to rapidly rule out those fractures? Yeah. Another example. Makes sense. Are you experiencing any roadblocks, any hesitations, whether from the industry as a whole, clinicians, or internally? I know you’re sort of CEO.
[00:06:26] You get that macro view, but what’s kind of on your radar there? The funding landscape is interesting on the investor side. And I guess the trend, and what we are raising for both platforms, they’re at different stages of financing and so on. So we’re kind of having discussions with the range of investors from seed through like growth equity, capital. And it is a difficult environment currently. It does seem like there’s this kind of hole in the middle between the seed,
[00:06:53] maybe seed rounds, five and under a million, maybe okay. You got the angel groups, the high net worth that can help fill that out. And then you’ve got the more established med tech capital that really wants to be, I feel like, more in the commercial scaling business. Let’s use the money to build up a commercial scale, which is more where we are with the epidural product. Yeah. And then maybe a lot of difficulty kind of in the middle, if you’re in the middle stage. Makes sense. Makes sense. Yeah.
[00:07:20] Do you have advice for folks out there who are maybe navigating those challenges on how to overcome that? Well, let me raise my round first and then I can get in the business of giving people advice on that. That’s right. You heard it from Will. He’ll be back to share with us in the future, which I’m sure will be the case. Yeah. All right. So we’ve talked about challenges. We talked a little bit about roadblocks, but just kind of speaking about the event here, anything that you’re really excited to see or have seen in addition to the robotics?
[00:07:49] In addition to the robotics prize, yeah. We were in the MedTech Innovator cohort last year. And so I always look forward to coming to events where there’s a MTI showing and getting to see friends there and also see those companies. There were two sessions here that were MTI companies, kind of alumni, and seeing, I mean, those are really high quality, like very polished, amazing technologies and presentations and really impressive stuff. Yeah, for sure.
[00:08:18] We’re out of that group. So it was really good to see the latest there and catch up with those folks. Love that. I love that. And anything that I always kind of like to round us out by thinking about predictions or things for the next year that you’re expecting to see, hoping to see? I’ve heard I went to J.P. Morgan early this year. In January. In January. Mm-hmm.
[00:08:42] And at least the feeling coming out of that was that maybe strategics may be wanting to come. The trend has been later, later, do deals when assets are commercial, generating revenue, well up a revenue ramp, but pay more. And I’ve heard there’s maybe some reasons to believe that the strategics may be wanting to come earlier to get to deals due to maybe limited pipeline of opportunities,
[00:09:09] maybe some of the investitures and spin-outs that are occurring. So I think that would be a welcomed trend. I don’t know if I predict that necessarily, but that’s definitely one I’m watching. Something. And anything else going into, I know we’re just getting into June as of next week, but we’re heading into that second half of the year. Things you want the audience to be aware of. That might be coming from you and your team. Things to watch out for. Stay tuned.
[00:09:34] We do have some big FDA clearances on the way for both product platforms on the epidural side. We’ve got one last technology feature for that platform before we go commercial, and that is a needle tip tracking technology that’s not ultrasound-based. It’s really cool technology. It is really enabling for the procedure. It’s currently pending. And then on the fracture side, we’ve got an AI model that we’ve trained at eight clinical sites, 1500 data sets.
[00:10:02] It’s got to be one of the largest 3D musculoskeletal with x-ray matched databases that exist. So that will be pending soon, and it’ll be exciting to get clearance there. Yeah, exciting to say the least. It sounds like lots of exciting stuff coming for you and the team this year. Is there a place that you want to give a shout out? So website, LinkedIn, where do you want people to, our listeners, where do you want them to kind of stay tuned? Yeah, follow us on LinkedIn. We’re very active there in posting updates. You can follow us there. Also our website, of course, rivannamedical.com.
[00:10:32] Awesome. Well, thank you so much. It’s been so great to have you on the episode. And like you said, we can’t wait to have you back so you can tell us advice for folks navigating this chapter. Yep, absolutely. All right, thanks. Yep. Take care.