The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary ...

As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...

A new system that combines high-speed video and an artificial intelligence (AI)-powered algorithm may offer quick, no-contact screenings for high blood pressure and Type 1 or Type 2 diabetes without ...

Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a ...

Pentamaster Corp Bhd’s prospects for the year ahead are expected to be underpinned by high-growth segments of the ...

Artificial intelligence (AI) is reshaping industries and our daily lives, from smart devices to healthcare and even the way ...

Michelle Tarver, MD, PhD, a 15-year veteran of the agency, is stepping into a pivotal role as the new director of the FDA's device division, taking over for Jeffrey Shuren, MD. Dr. Shuren's tenure was ...

Artificial intelligence will soon help doctors detect cancerous lesions in real-time during endoscopic procedures, through a new collaboration between medical device company Optiscan Imaging Ltd ...

Penn State's electronic tongue, enhanced by AI, detects subtle variations in liquids for food safety and diagnostics, with ...

NPR's Ayesha Rascoe speaks with U.S. FDA Commissioner Robert Califf about the agency's process for regulating artificial intelligence in healthcare.