On June 25, 2026, UpDoc Inc., a clinical AI company, announced that it received clearance from FDA for what the company describes as the ...

Healthcare workers need enough AI literacy to use the tools safely, question their limits and know when human judgment must ...

With an initial indication for type 2 diabetes, SaMD developer UpDoc says its platform is designed to support doctors, not ...

The FDA has been steadily laying the groundwork for a comprehensive framework around artificial intelligence (AI) in software as a medical device (SaMD). The culmination—at least for now—arrived in ...

As AI tools increasingly handle sensitive health data, experts warn that most consumer chatbots are not bound by HIPAA, raising privacy risks. Health systems and regulators are moving toward ...

The US Food and Drug Administration (FDA) requested feedback Tuesday on a new discussion paper that proposes applying a “focused review” approach to premarket assessments of software as a medical ...

Healthcare innovation is advancing rapidly as healthcare systems speed up adoption of AI technologies. In 2025, healthcare AI spending hit $1.4 billion, nearly tripling 2024’s investment. Regulation ...

The US Food and Drug Administration has released a five-part action plan for its oversight of artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) based on ...

Any doctor knows that the road to clinical licensure is long and winding. After medical school, it requires internship, residency, fellowships, written exams, and continuing education credits.

Ultrasound AI, a pioneer in artificial intelligence applications for medical imaging, today announced it has received FDA De Novo clearance for its flagship Delivery Date AI technology, a cloud-based ...