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October is recognized as Cybersecurity Awareness Month, highlighting the importance of safeguarding sensitive data and
Starting October 2025, the U.S. Food and Drug Administration (FDA) will require all De Novo
The U.S. Food and Drug Administration (FDA) has officially released its highly anticipated guidance on
In a bid to harmonize regulatory practices and streamline the approval process for medical technologies,
In a significant move to address a critical gap in the healthcare industry, a new
Background and Problem A US based manufacturer of sample preparations reagents and instruments needed an
In a significant move toward enhancing the safety and efficacy of machine learning-enabled medical devices
In response to increasing concerns over supply chain stability and its impact on healthcare delivery,
In a move poised to reshape the regulatory landscape for in vitro diagnostics (IVDs) across
