In the winner-takes-all market of BCI, Science Corp's new “biohybrid” could disrupt industry giants like Neuralink, Paradromics, Synchron, and others, who have collectively raised over $1 billion.
Does biohybrids really threaten active medical implants? Hmm, let me think. When you speak to the FDA, which has CDRH and CBER, the first question they ask is is it a device or a (bio)pharmaceutical or a cell/gene therapy? It is then partitioned to those centers for review and advice. In the case of biohybrids, who reviews them? CDRH as a device or a CBER as a cell/gene therapy?
The FDA never has expertise to review the two togetehr and with recent changes, probably never will, again. So I am failing to see the logic beyond science that it will make a dent in anything.
Holy sh*t Aryan. Super helpful! Bookmarked for reference.
Thanks Naveen for everything you do, and be sure to subscribe!
Does biohybrids really threaten active medical implants? Hmm, let me think. When you speak to the FDA, which has CDRH and CBER, the first question they ask is is it a device or a (bio)pharmaceutical or a cell/gene therapy? It is then partitioned to those centers for review and advice. In the case of biohybrids, who reviews them? CDRH as a device or a CBER as a cell/gene therapy?
The FDA never has expertise to review the two togetehr and with recent changes, probably never will, again. So I am failing to see the logic beyond science that it will make a dent in anything.