In this week’s roundup: Watching for a restart to FDA user fee talks and Califf’s confirmation. EU steps on standards, companion diagnostics, health technology assessments, and notified bodies. FDA progresses on quality system harmonization and device shortage notifications, and forges a new imaging office. More from the US, Canada, UK, and Singapore.
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Equity investments from strategics are great for promising start-ups…until they’re not. Transcatheter mitral valve repair company HighLife thought it had found an alternative to traditional venture funding with an investment from a strategic. But several years into the relationship, the strategic had second thoughts, leaving HighLife scrambling to stay in business.
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