“Our findings help quantify how these adverse events increase estimated direct medical costs and negatively affect radiology workflow," experts write in JACR. 

Back in August, the agency outlined plans to grant faster coverage for “breakthrough” devices in radiology and other specialties, dubbed “RAPID." 

“These factors raise substantial doubt as to the company’s ability to continue as a going concern,” the Israel-based device manufacturer said Oct. 16. 

The effort is aimed at addressing a key challenge in nuclear medicine—the short half-life of many radiopharmaceuticals.

HER2-positive tumors account for around 20% to 25% of breast cancer cases and are known to often be more aggressive.

Chicago-based software developer SimBioSys announced the regulatory win on Oct. 15, with the decision applying to its TumorSight Risk offering.

Overall, more than 950,000 clinicians submitted queries to a popular AI platform from January 2024 to June 2026. Cardiovascular care was a common topic, especially questions about specific treatments and medications. 

Certain Sapien M3 TMVR delivery systems have been linked to a risk of malfunctioning in a way that puts patients at risk. The devices included in this early alert should be returned to the manufacturer. 

Insider explains how the FDA is spearheading the Trump administration's push for faster AI adoption in healthcare.