HN user
Horrific stuff seeing the level of expertise leaving the building at FDA. Some of the program managers I’ve dealt with in the past have taken the payout with their roles left vacant. Just absolutely abhorrent levels of leadership, the 30 day response timeframes for submissions is starting to produce some sloppy work on their side.
I’m currently arguing a statistical plan for a neurostim phase two clinical trial IDE submission with the FDA. We got some borderline reckless comments back that are massively out of line with correspondence on previous pivotal submissions. It’s starting to look like some of the reviewers are taking on work outside the scope of their expertise. Really disappointing to see, especially with the new more streamlined MDR reqs coming out of the EU.
It's an FDA guidance doc so you can expect to see this affecting new filings or supplemental filings for upcoming FDA submissions and clinical trial designs. This is good news, statistical plans are always a point of contention during trial design and the submission process. This guidance lays a line in the sand and will remove some of the reviewer-to-reviewer variance present in the current FDA staff.
why is hims and hers listed as a tech company?
This guy always has an unreal amount of engineering lift for hobby videos. A treat to watch every time.
One of the biggest unsolved issues with BCI and neural implants is the immune response to implanted electrodes. The tissue buildup and fluid that encapsulates the probe or stimulator drastically increases the impedance of the device and causes all sorts of hard to solve problems for longevity of the implant and whatever therapy or recording it's trying to accomplish.
Is gaffer's tape the top pick or is there another, higher tier of tape?