Medical Devices

• The FDA has awarded breakthrough device designation to more than 1,200 experimental devices, including AI innovations, since 2016. • Evolving FDA criteria reflect accelerating AI integration in US health tech approvals. • Program speeds market access for transformative devices addressing unmet medical needs.

• Stryker, a major US medical device manufacturer, suffered a cyberattack causing widespread business disruption, reported on March 27, 2026. • The company stated operations are steadily improving toward full capacity after the incident. • This incident highlights ongoing cybersecurity vulnerabilities in US healthcare tech supply chains.