House Energy and Commerce Committee members crafting a pandemic-planning reauthorization bill are adding device cybersecurity details to the language to help maintain the nation’s stockpile of countermeasures to infectious disease outbreaks and chemical, nuclear and biological attacks.
US lawmakers working to reauthorize a pandemic preparedness bill known as “PAHPA” plan to add provisions on maintaining cybersecurity in medical devices purchased for the national stockpile of emergency countermeasures. But recent changes in FDA authority over software products raise some questions with the issue.
Devices, personal protective equipment, pharmaceuticals and vaccines are part of the stockpile maintained by federal agencies in the case of...
J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.
In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.
US FDA Commissioner Marty Makary says the agency’s generative AI tool ‘Elsa’ will allow employees across the FDA to work more efficiently. The commissioner says Elsa’s launch comes ahead of schedule following a successful pilot program.
