The FDA granted 510(k) clearance to two devices, HyHub and HyHub Duo, that act as docking stations for dual vial units to ...

MAGiC Sweep is claimed to be the first robotically navigated electrophysiology mapping catheter approved by the FDA.

A dozen lawsuits have been filed over spinal cord stimulators, which are medical devices surgically implanted to reduce chronic back pain. The suits name device manufacturers, such as Abbott and ...

The Food and Drug Administration has identified a Class I recall of Edwards Lifesciences OptiSite Arterial Perfusion Cannula ...

Numerous medical devices sold in the United States are subject to active recalls. If you have a medical device that is ...

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.

The US Food and Drug Administration (FDA) has approved Boston Scientific’s expanded instructions for use (IFU) labelling of the Farapulse pulsed field ablation (PFA) system. The approval marks a ...

The FDA has quietly authorized more than 1,000 medical devices incorporating artificial intelligence or machine learning, marking a significant growth of AI in healthcare. The agency’s AI/ML ...

FDA Will Use AI to Approve Drugs and Devices Faster The agency launched a large-language model, dubbed Elsa, just last week to streamline operations.

The FDA updated a recall on tomatoes potentially contaminated by salmonella to the most serious classification. Here’s which products were recalled in South Carolina, North Carolina and Georgia.