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Most enterprises already have AI running inside their businesses. Many just don’t realise how widespread it has become. It includes the growing use of shadow AI, AI tools adopted by employees without formal oversight or approval. Palo Alto Networks found that generative AI traffic across enterprise networks grew by more than 890% during 2024 after studying usage […]

FDA says 510(k)s submitted after October 1, 2023, must be submitted electronically using eSTAR, unless exempted. This move has led to a consistent approach to data collection during the initial acceptance period, but added to the technical review burden in the substantive decision-making phase. Moreover, recent financial reports show the average Total Time to Decision […]

An fda deficiency letter can slow a submission just when your team expects movement. It can affect launch planning, testing budgets, clinical work, software evidence, cybersecurity documentation, labeling updates, and quality records in one review cycle. The term can also be confusing. The FDA does not use a single deficiency letter across every product pathway. In medical […]

According to IBM’s 2025 Cost of a Data Breach Report, 13% of organizations reported breaches involving AI models or applications. In 97% of those cases, the affected organizations said proper AI access controls were missing. Model inversion attacks are one example of the growing risks facing AI systems, allowing attackers to potentially infer sensitive information from model […]

Medical devices have changed a lot in the last few years. Many now connect with hospital networks, mobile apps, cloud platforms, and remote monitoring systems. While this has improved patient care, it has also created new security problems. Making compliance with the FDA cybersecurity checklist essential for manufacturers developing connected medical devices. Hospitals across the US have […]

A few years ago, most medical devices worked inside closed hospital systems. That is no longer the case. Today, devices connect with cloud platforms, mobile apps, Bluetooth networks, APIs, and remote monitoring systems every day, making medical device threat modeling an important part of healthcare cybersecurity.  A patient’s data may travel through several systems before it even […]

Every 39 seconds, a cyberattack hits an organization, resulting in more than 2,200 incidents every single day. The organizations that handle sensitive information, such as Protected Health Information (PHI) and financial data, are under perpetual pressure to show correct and verifiable security measures. However, managing multiple regulatory requirements independently leads to complexity, duplication, and inconsistent […]

Around 71% of organizations can fail their first security audit or face major delays due to inadequate control implementation and a lack of evidence. While many organizations develop security programs that are “compliant on paper”, they fail to have the level of detail, consistency, and traceability needed to effectively prove that they are compliant. HITRUST […]

As of early 2026, the FDA’s publicly updated list under its FDA Guidance on AI in Medical Devices shows 1,451 AI-enabled medical devices authorized for marketing in the United States since 1995, with approximately 295 new authorizations in 2025 alone. Radiology continues to dominate, accounting for about 76% of all authorizations, or roughly 1,104 devices. […]