Medical Design & Outsourcing

FDA rules, regulations and resources for artificial intelligence in medical devices

Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...

FDA Cyber Guidance Sets Priorities for Medical Device Companies

Opinion: In response to the FDA's updated cybersecurity guidance on medical devices, manufacturers should follow "secure by design" principles, ensure cyber transparency, conduct threat modeling, and ...
Los Angeles Times

The Life-or-Death Stakes of Medical Device Cybersecurity

Ransomware attacks on the healthcare sector surged by 30 percent in 2025, frequently disrupting operational technology and medical devices. FDA Section 524B mandates that manufacturers provide a ...
JD Supra

AI wellness or regulated medical device? A lawyer's guide to navigating FDA rules—and what could change next

As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that ...
MD&M East

Factors Influencing FDA Clearance Time for Medical Devices: Evolution of a Critical Regulatory Pathway

The landscape of FDA medical device regulation has undergone a significant transformation. Today's regulatory environment presents both familiar challenges and entirely new complexities that device ...