Medical devices are becoming more capable, more complicated, and more deployable in the field rather than in a hospital or a ...

The Food and Drug Administration has introduced a new AI tool that could expedite the review and approval process for medical ...

MINNEAPOLIS, May 15, 2025 (GLOBE NEWSWIRE) -- Elucent Medical (“Elucent”), a leading innovator in the field of guided surgical technologies, announced today that the U.S. Food and Drug Administration ...

Alpheus Medical announced today that it closed an oversubscribed Series B financing round, bringing in $52 million. The Chanhassen, Minnesota–based solid body cancer treatment developer plans to ...

To take the guesswork out of breastfeeding, an interdisciplinary team of engineers, neonatologists and pediatricians at Northwestern University has developed a new wearable device that can provide ...

AI-enabled medical devices present additional risks that must be closely considered. Credit: MUNGKHOOD STUDIO/Shutterstock. Between 2022 and 2027, leading data and analytics company GlobalData ...

In Part 1 of this series, I explored how countries across the globe are shaping regulatory frameworks to manage the rapid integration of artificial intelligence (AI) and machine learning (ML) in ...