The AI Touch: Artificial Intelligence Could Boost Quality Systems, Cut FDA Inspections – But Is Industry Ready?
• By Shawn M. Schmitt
As the medical device industry begins to push the boundaries of artificial intelligence – exploring ways to use advanced AI systems to review, sort and process big data to find quality systems or product problems that would simply take too long for human eyes to see – FDA is also looking at ways to use AI for its own advantage. "AI will reduce investigational time and increase FDA's speed in taking action on a problematic firm," one agency official says. Meanwhile, a new Artificial Intelligence Initiative has been launched by Xavier University to better determine how AI can be used in the quality and regulatory space. Also: J&J subsidiary Janssen explains how it uses AI for quality and regulatory applications, and an expert from Shire tells how top management can be convinced that using artificial intelligence can save their firms money.
Pioneering device-makers that use advanced artificial intelligence systems to analyze their vast streams of data to pinpoint predictive outcomes for quality systems and marketed products could one day see fewer US FDA facility inspections, an agency official says.
Art Czabaniuk, program division director/district director for the Division of Pharmaceutical Quality Operations III within FDA's Office of Regulatory Affairs, foresees "great benefit from AI in the regulatory environment" – especially
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Out-of-hospital cardiac arrest remains one of the most challenging and resource-intensive emergencies in cardiovascular care. At SCAI 2025, clinicians presented a novel algorithm that improved triage decisions and reduced unnecessary interventions.
Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.
King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.
Apple and Synchron are teaming up to develop technologies that will one day allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.
While the initial focus is medical devices and life sciences, Ketryx sees future opportunities in other high-regulation sectors including automotive, aerospace and defense, pharma manufacturing and nuclear systems.
After publishing encouraging results from first-in-human trials of its brain-computer interface, Axoft announced plans to sell its BCI-enabling material Fleuron to researchers and private organizations for R&D use. The company sees this as a revenue stream and feedback loop to refine its BCI platform designed for safer, longer-lasting brain implants.
Digital pathology makes it possible to unlock insights previously hidden to the human eye, “reshaping how we diagnose and treat patients,” said Nathan Buchbinder, co-founder and chief strategy officer at Proscia. He shared his views on the future of digital pathology and the lessons he has learned from working with pathologists.
