Resolution criteria
Resolve YES if, by 11:59:59 pm Eastern Time on December 31, 2029, the U.S. FDA grants any marketing authorization for human use (approval, licensure, De Novo grant, or 510(k) clearance) to a product that fits this definition: a living, multicellular construct assembled ex vivo from animal or human cells, engineered to perform autonomous tasks in vivo (e.g., locomotion/drug delivery)—i.e., a “xenobot/biobot/anthrobot”-type product. Verification must appear in one of the FDA’s public databases: Drugs@FDA (NDAs/BLAs), Purple Book (licensed biologics), PMA, De Novo, or 510(k). Links: Drugs@FDA, Purple Book, PMA, De Novo, 510(k). (fda.gov, accessdata.fda.gov)
EUAs, INDs/IDEs, in vitro–only/research-use-only authorizations, animal-use approvals, or products consisting solely of dissociated cells or live microbes (e.g., standard cellular therapies or live biotherapeutics) do NOT count. Market resolves NO otherwise.
Background
“Xenobots” were first reported in 2020: AI-designed, frog-cell (Xenopus laevis) constructs that move and perform simple tasks; later work showed kinematic self‑replication in vitro. (pnas.org)
Related “anthrobots” made from human airway cells (no genetic modification) self‑assemble, move via cilia, and promoted neuron repair in vitro; still preclinical. (wol-prod-cdn.literatumonline.com, now.tufts.edu)
If regulated for human use, such living constructs would likely fall under CBER (BLA/licensure) or, less likely, device pathways (PMA/De Novo). See FDA overviews of BLAs and De Novo/classification. (fda.gov)
Considerations
Naming is nonstandard; an approved product may be branded without using “xenobot.” For YES, the FDA decision/label must describe a living multicellular construct engineered ex vivo to act autonomously in vivo (not a conventional cell therapy or probiotic).
Traders should monitor FDA databases above; biologics appear in the Purple Book and Drugs@FDA, while novel devices appear in De Novo/PMA/510(k) listings and decision summaries. (fda.gov)
1,000