USA – FDA takes a step forward for machine learning with quantitative imaging guidance
The US Food and Drug Administration finalized guidance on what to consider when using quantitative imaging algorithms in radiological device submissions. While most imaging...
Europe – Euro Roundup: European Commission proposes streamlining regulations to boost biomanufacturing
The European Commission is set to assess how to streamline regulatory pathways for the biotechnology and biomanufacturing sector as part of a broader push...
Europe – SSCP expert lists common mistakes device manufacturers make
Some of the most common mistakes manufacturers make when complying with safety and clinical performance (SSCP) requirements may sound simple enough to fix, but...
