NeuraNova cleared a 510(k) this month for a device that reads fluid asymmetry inside the skull. The hardware is bioimpedance spectroscopy and it's genuinely clever. The part of that submission worth studying, though, is one sentence of plain English.
What the indication sentence actually does
A 510(k) runs two equivalence tests and they run in order. First the indication: is what you say your device is for substantially equivalent to what the predicate is for? Then technological characteristics, which is looser and depends on how different your engineering really is. Most founders pour their energy into the second test. The first one is where submissions die.
NeuraNova's cleared wording says the device aids "in the assessment of" fluid volume asymmetry between the cerebral hemispheres, in adult patients who are already undergoing a neurological assessment. The company describes it as "an adjunct to standard clinical evaluation" methodologies.
Now count what that sentence declines to do. It doesn't diagnose, and it doesn't use the word stroke anywhere. It aids an assessment a clinician is already performing, and it sits beside the existing standard instead of replacing it. Those are boundaries the company drew on purpose, and every boundary it drew shrank the pile of evidence it had to produce.
The submission behind the clearance was engineering validation, repeatability testing, software verification and validation, and risk management review. No clinical outcomes trial. That isn't a loophole. That's what an evidence base looks like when the claim is scoped to what a bench can actually prove.
Why "better" is the expensive word
The trap here is the marketing instinct. A founder who has spent four years on a sensor wants the indication to say the device finds the bleed faster than what's in the room today. The moment you write faster, or more accurate, or better, you've made a superiority claim. Superiority is definitionally not equivalence, and asserting it can push you out of the 510(k) lane and into a review nobody budgeted for.
The disciplined version argues that your differences are safely evaluated inside the same bounds as the predicate. Not better. Equivalent, done a little differently, with an engineering reason the difference raises no new question of safety or effectiveness.
One thing I noticed: NeuraNova used to be called StrokeDx. The cleared sentence doesn't mention stroke. I have no idea whether the rename and the indication language were the same decision and I'm not going to pretend I do. But the gap between that old company name and that cleared claim is roughly the gap most hard-tech founders have to close before a submission is ready.
Whose job that sentence is
This is where I'll argue with how most companies staff the work. The indication gets filed mentally under regulatory paperwork, so it goes to the regulatory consultant, who writes it late, after the engineering is frozen. That's backwards. Deciding what the product is, in one sentence a regulator will accept, is product strategy, and it belongs to whoever owns binding the product to a market.
I learned that the expensive way. At Galen we first framed the robot as substantially equivalent to a remote-control telemanipulator, with da Vinci as the predicate. The FDA didn't buy it. We reframed the same hardware, physically unchanged, as a device that improves a surgeon's access at the end of a long instrument, and that framing went through as a De Novo. We ended up drafting the regulation ourselves and the agency took our language almost word for word. The machine never changed. The sentence did.
Change that sentence after the design history file is written and you get to reconcile every document sitting behind it. Nobody budgets for that either.
The founders I watch get blindsided by the FDA are almost never blindsided by the engineering. They're blindsided because a claim somebody made casually in a pitch deck two years ago is now a claim they have to defend with data. Write the indication sentence early, say it out loud with your engineering lead and your regulatory advisor in the same room, and make everything downstream agree with it. It's the cheapest work in the program and it's the piece most teams leave for last.
From Dave’s video library
In this one I walk through the three jobs a founder keeps on purpose, and Direction is the one that covers calls like this.
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Dave Saunders is the founder of Base Reality Group and a Fractional CPO for hard-tech founders. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →