Synapse Biomedical expects FDA to issue a humanitarian device exemption within weeks allowing its NeuRX diaphragm pacing system to be marketed to treat patients with amytrophic lateral sclerosis.

First genetic test for warfarin sensitivity cleared: Nanosphere's Verigene multiplex nucleic acid test for genetic variations that influence metabolism of the common blood-thinner warfarin is 510(k)-cleared Sept. 17. FDA updated the labeling of warfarin in August to explain that patients with variations in the CYP2C9 and VKORC1 genes may respond differently to the drug (1"The Gray Sheet" Aug. 20, 2007, p. 9). Other firms developing warfarin test kits include AutoGenomics, Nanogen, Third Wave Technologies and Luminex

Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.