FDA Approvals - Seizure Detection Algorithm: FDA Clearance sought (Scoop.co.nz) BrainZ Instruments Limited
Seizure Detection Algorithm: FDA Clearance sought (Scoop.co.nz)
BrainZ Instruments Limited (ASX:BZI) today announced it has lodged a submission with the United States Food and Drug Administration ( FDA ) for its computerassisted seizure detection algorithm1.
MDS pushes to resolve issues at Montreal lab after Q2 profit withers to $16M (Canadian Business)
TORONTO (CP) - Resolving issues at its Montreal laboratory is MDS Inc.'s "No. 1 priority" after reporting Thursday that problems at the facility continued to drag on profits and threatened to delay key regulatory approvals.
Going From The Lab To Limbo (BusinessWeek)
The FDA has been delaying decisions on applications, and drugmakers are fuming