FDA
Medtronic recalls pH monitoring capsule linked to 184 serious injuries
Medtronic announced a recall of its Bravo CF pH monitoring capsules, which may fail to attach properly or detach from the esophagus, leading to serious injuries. The U.S. FDA issued an early alert on Thursday, having received 184 reports of serious injuries as of August 10, with no deaths reported. The recall involves product batches that were partially recalled last year, but the root cause is different.
How can wearables be used in clinical trials? FDA outlines best practices
As more clinical studies incorporate digital health technologies such as wearable devices, the FDA released best practices on Thursday to guide researchers in validating technologies and ensuring that measurement metrics are meaningful to patients. Rick Abramson, Director of the FDA's Digital Health Center of Excellence, outlined key principles in a blog post, echoing the Center for Devices' efforts in real-world evidence.
Trump nominates policy aide Overton to lead FDA
President Donald Trump on Wednesday nominated Heidi Overton, a top White House policy aide and physician, as the next FDA commissioner. If confirmed, she would fill a leadership void that has persisted since Marty Makary resigned in May. Overton's limited drug regulatory experience has raised questions among industry analysts about her potential impact on biopharma policy.
Device industry supports new MDUFA agreement, patient groups call for strengthened post-market safety oversight
At a public meeting on Wednesday, the U.S. medical device industry broadly supported the latest version of the Medical Device User Fee Amendments (MDUFA VI) negotiated between the FDA and industry, covering fiscal years 2028 to 2032. Annual fees for domestic companies remain largely stable or slightly lower, while fees for overseas companies will increase. Patient groups, however, called for greater attention to post-market safety and suggested using real-world evidence for post-market surveillance. The FDA plans to complete congressional submission and budget approval by September 2027.