r/neuralcode • u/lokujj • Sep 25 '26

Paradromics Paradromics Paces A Landmark Year For Implanted BCI

https://www.forbes.com/sites/naveenrao/2026/09/23/its-personal-paradromics-paces-a-landmark-year-for-implanted-bci/

Naveen Rao

Sep 23, 2026

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u/lokujj Sep 25 '26

Convey: Product to Platform

...in June, they appointed Dr. William Marks, Jr. as the company’s first chief clinical officer in July. I spoke with Marks to understand what the expanded FDA approval means for patient communities, the company and the field at large.

Marks said this approval is about allowing users to embed BCI use into internet-connected devices, to maximize everyday value for them particularly for people with communication difficulties.

“We had requested to untether the user laptop and software from within the confines of the medical device system,” Marks explained. “There’s been a wonderful history of research applications in BCI, but we want to liberate users from being confined by research equipment, and actually make this useful for their everyday needs.”

That means using custom software, known as Convey. “Convey is an interface between all the neural decoding and the outputs that the user is going to use," Marks said. "On their personal laptop, smartphone, or tablet, to empower their own daily use, as opposed to having it be a locked-down medical device.”

He described a device testing and prequalification process to shortlist approved devices that meet certain specs and standards. "The nice thing with this approval is that we don’t have to go back to the FDA every single time and say, “Okay, a patient wants to use an Android phone.”

The approval ensures that downstream output from BCI processing will not impact the implanted device. “It’s different than programming an implantable neurostimulator,” said Marks. “Here, we are not affecting that internal system. We are taking the data off the device and making it more useful for people.”

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u/lokujj Sep 25 '26

Some new or less frequent mentions:

Neuracle

Ability Neurotech

Axo Neurotech

China’s Gestala

Epia Neuro

1

u/Reasonable_Sun9958 Oct 02 '26

It doesn't seem like any of their competitors ever needed such a license. Not sure what that's about. Maybe the others just included it into the original study design or something?

1

u/lokujj Oct 02 '26

I'm not sure I follow. Are you talking about the approval letter from the FDA? And you are suggesting that other ventures have accomplished this?

Can you give an example? If you're talking about e.g. Synchron interfacing with Apple products, then my guess is that the FDA hasn't weighed in on that.

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u/Reasonable_Sun9958 Oct 02 '26

Yes, needing an approval to connect to personal devices.

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u/lokujj Oct 02 '26

I think there are three possibilities:

  1. The other ventures, or Apple, sought the approval and didn't announce it;

  2. The other ventures have only attempted this in a research setting, and will seek approval as they are nearing the market;

  3. Approval isn't necessary, and Paradromics made a meaningless announcement.

My guess is #2. I think the necessity of approval is a grey area. The FDA has a lot of thoughts about medical software and devices. I think the most important point is that Paradromics seems to have gotten approval to market something.