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The White House Office of Management and Budget (OMB) signed off late last week on the FDA’s proposed rule to harmonize its Quality System Regulation (QSR) with the International Organization for Standardization (ISO) 13485. Read More
Endra said it will send the FDA additional limited confirmatory clinical data from a subset of its existing clinical evaluation sites, which it expects to receive this year. Read More
Johnson & Johnson subsidiary DePuy Synthes has acquired CrossRoads Extremity Systems, a Memphis, Tenn.-based company that will strengthen DePuy’s portfolio in elective foot and ankle implants and surgical instruments. Read More
Two Canadian companies, Imagia Cybernetics and Canexia Health, are merging to create a new entity that will focus on genomic testing and analysis for cancer patients. Read More
Cambridge, Mass.-based Foundation Medicine has teamed up with Eli Lilly for the development of tissue- and blood-based assays as companion diagnostics for Lilly’s cancer drug Retevmo and other therapies. Read More