FDA’s AI Tool Won’t Make Regulatory Decisions, Official Says

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

(Shutterstock)
Key Takeaways
  • The FDA will not use its Elsa AI platform to make decisions on drug approvals, Tala Fakhouri told the DIA Global Annual Meeting.

The US Food and Drug Administration is not using its Elsa generative artificial intelligence tool for regulatory decisions, associate director...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA

Biden-Era Device Trial Snapshot Pilot Halted Amid DEI Policy Shift

 
• By 

The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

More from Digital Technologies

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.

Scores Of Companies On Board With Medicare Data Interoperability And Digital Health Initiative

 

The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.

J&J MedTech’s Digital Head Pushes For Smarter, Standardized ORs With AI And Open Tech

 
• By 

J&J’s global head of MedTech Digital envisions AI-powered connected operating suites within a decade. In an interview with Medtech Insight, Shan Jegatheeswaran discusses how J&J, together with partners like NVIDIA and AWS, is laying the foundation for open platforms for standardized surgeries.