SHORT CIRCUIT: A federal appeals court said that the Food and Drug Administration made the right call in rejecting fast-track approval of two Cytori Therapeutics Inc. devices used to process adult stem cells.
SPIN DOCTORS: Cytori devices separate adult stem cells from fat tissue with a combination of spinning and chemical reactions. The company appealed an FDA decision in 2011 that said it needed a more rigorous approval process.
REWIND: Cytori has begun a large study it will use to seek traditional FDA approval. It will evaluate stem cell injections as a treatment for patients with heart disease.
- Pharmaceuticals & Drug Trials
- Food and Drug Administration
- federal appeals court
- adult stem cells