FTC challenge to Edwards JenaValve acquisition may delay FDA clearance | Cardiology tops FDA breakthough devices | Mo99 supply

Edwards Lifesciences asked the U.S. Federal Trade Commission (FTC) this week to dismiss the complaint against the company's acquisition of JenaValve this week. A healthcare market analysis firm also said the FTC actions will likely impact the timing of an FDA clearance of the Trilogy heart valve.

Greg Piefer, PhD, chief executive and founder of Shine, a Wisconsin-based radiopharmaceutical company that is building the world’s largest medical isotope production facility in Janesville, Wisconsin, explains progress on the company's fusion reactor that will become the first sustained U.S. commercial supplier of molybdenum-99 in decades.

Cardiology is number one in FDA Breakthrough Device designations at 218, the highest number out of all other clinical categories. This includes 16 new devices cleared in the past year.

The new drug, VTB-10, previously received the FDA's orphan drug designation in 2024.

“It is your responsibility to be the patient’s advocate,” one expert explained. “We, as the nurses and technologists, have to speak up when we see something that isn’t right.”

Transcatheter patent ductus arteriosus (PDA) closure has been a mainstay in congenital interventional cardiology for decades, but changes in the standard of care have resulted in catheter-based treatments overtaking surgical procedures. 

More and more care teams are treating BAV stenosis with TAVR instead of surgical aortic valve replacement. Self-expanding and balloon-expandable valves appear to have their own benefits—as well as their own risks. 

The roots of medicine are in the promotion of human welfare, aka humanitarianism. Healthcare AI can either degrade or reinforce this heritage. Who picks the path? 

Mahendra Amin, MD, sued Amazon and its podcast subsidiary, Wondery, after a show host accused him of performing forced hysterectomies on women detained at an ICE facility. The claims were popularized by MSNBC, which settled a similar lawsuit with the doctor earlier this year.

Researchers at the University of Edinburgh found that cats with dementia, like humans, have protein buildup in synapses that impacts cognitive function and memory.

New research published in Lancet Digital Health details the improved cancer detection rates achieved when AI serves as a second reader. 

The agency recently issued a frequently asked questions fact sheet about the WISeR model days after House Democrats expressed concern about the initiative. 

Autumn Bardisa of Palm Coast, Florida, is accused of providing a stolen license number to earn employment at an AdventHealth hospital, where she worked for over a year despite lacking the required education and credentials. She’s been charged with fraud.

Some Baxter Novum IQ pumps have a software issue that can cause the “run” screen to go blank or trigger another system error, potentially resulting in inadequate infusion. The company has issued updated use instructions to ensure safe operation.