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As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, suggests clinical considerations for medical device developers and anticipates AI-enabled SaMDs’ future progress.

Despite ranking among the world’s top scientific producers, Italy has struggled to turn research into startups. Now, stronger tech transfer offices, private capital and returning scientists are pushing the country toward a more mature innovation economy.

Leinfelden, Germany. Recent infectious disease events—from hantavirus outbreaks and meningitis cases to recurring disease outbreaks in livestock farming—highlight the need for flexibly scalable vaccine manufacturing processes. To address this challenge, Stuttgart-based technology company KyooBe Tech has developed a platform designed to accelerate vaccine production. This technology is now also available to external users for studies at the Fraunhofer Institute for Cell Therapy and Immunology (IZI).

The acquisition gives Johnson & Johnson access to Firefly Bio’s next-gen platform designed to create degrader antibody conjugates that can crack the tricky KRAS cancer target.

At this year’s annual meeting of the Bio International Convention (BIO) in San Diego, CA, TechBio company Cytomos (www.cytomos.com) is showcasing their flagship cell analytic intelligence platform AuraCyt® – together with its novel benchtop technology Celledonia® – which is set to revolutionise predictive cell analytics.

Novartis stands alongside Big Pharma peers that have similarly invested in technologies to penetrate the blood-brain barrier, including GSK, Roche and Eli Lilly.