SetPoint Medical announced today that the FDA approved its SetPoint neuroimmune modulation system for treating rheumatoid ...

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

From softwares to implants, here are 10 spine products earning FDA nods since May 15. 1. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions.

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

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

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 ...

KalVista has become the latest biotech to face delays to FDA decision-making, as the agency blames a “heavy workload” for pushing back a PDUFA date.

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.

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.

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.

On May 2, Williams Repack LLC. announced a recall of tomatoes produced on their farms due to potential salmonella contamination, and the FDA updated the recall to Class I on May 28.