FDA Issues Discussion Paper Regarding Regulation of Generative AI-Enabled Medical Devices
The United States Food and Drug Administration (“FDA”) recently issued a discussion paper that sought feedback regarding the regulation of generative artificial intelligence-enabled medical devices. Statements from the FDA highlight...
Stryker Provides Update After Cyberattack
According to a press release, Stryker Corporation recently “experienced a cybersecurity attack which resulted in a global disruption to Stryker’s (internal, corporate) Microsoft environment.” A cyberterrorist organization, Handala, reportedly claimed...
U.S. Considering Tariffs on Med Device Imports; Trade Groups Push Back
The Commerce Department is investigating whether imports of personal protective equipment (PPE), medical consumables, and medical devices and equipment have national security implications that may warrant trade action, such as...
