Results of their clinical trial look positive.

https://pubmed.ncbi.nlm.nih.gov/39289373/

Keep in mind that paper cited isn't really the clinical trial that shows improvements in symptoms. It just shows their device works and can record LFP properly....

The actual clinical results so far shows that the gizmo with recording is not necessarily worse than DBS devices that don't have recording ability. I don't know if they published those results in a paper yet, but it was shown in poster form at MDS congress in Philly.

Any idea what a clinical trial to approval roadmap might look like? Vested interest.

not sure - but it will likely be quicker because the software is sort of already built into current generation Medtronic devices. They are not trying to approve a whole new device, probably just the software that switches the device on/off.

That being said, there are also reasons at the moment (better imaging support/stimulation programming abilities) to sometimes choose a competitor device over Medtronic (namely Boston Scientific)

Better DSP/ML techniques might make this more effective, but uh...the Parkinson's research community has never been known to be great at math...just saying

DBS devices have been in the market for years already and helping patients. This is just an incremental improvement.