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Implantable Bioartificial Kidney FDA Approval

Question

The team of scientists behind The Kidney Project has created an implantable bioartificial kidney that consists of a hemofilter module to process incoming blood and a bioreactor that sends sugars and salts back into the blood.

The website for the project states that the project team is "in the midst of preclinical testing for the Hemofilter, while preclinical testing for the Bioreactor has just begun."

The website further states that the project team "expect[s] to arrive at [the] final stage of clinical trials by late 2021."

Will The Kidney Project's implantable bioartificial kidney receive FDA approval before 2025?

The question resolves positively if the FDA grants approval to the current version (or a substantially similar version) of the implantable bioartificial kidney developed by The Kidney Project. Otherwise, the question resolves negatively.

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