This recall is due to reports of “increased resistance” when using the devices. There have been 194 customer complaints about the issue so far. 

Less than two months after an FDA advisory panel voted in favor of approval, the transcatheter edge-to-edge repair system can now be sold and marketed in the United States.

The recall is due to ongoing concerns about the devices breaking. Three patients have been injured as a result of this issue.

Cardiologists were asked to develop a care strategy for CAD patients before and after using an FDA-approved AI tool to evaluate CT results. In two out of three cases, the AI influenced cardiologists to modify their original plan. 

"I wasn’t expecting these results among women in this lower age group, because we usually see increased risk for heart disease among older women," one cardiologist said. "It was definitely surprising.”

Eko Health worked closely with Mayo Clinic to develop and evaluate its latest AI offering. “Importantly, since a stethoscope is small and portable, this technology can be used in urban and remote locations," one clinician said. 

Leaders from the American Heart Association, American College of Cardiology, Heart Failure Society of America, Heart Rhythm Society and Society for Cardiovascular Angiography & Interventions have shared their vision for a new, independent Board of Cardiovascular Medicine.

Research published in 2018 caused many in the cardiology community to shy away from using these devices, and the FDA even issued warnings about their safety. However, new data suggest paclitaxel-coated balloons and stents are safe. 

Transcatheter pulmonary valve replacement is still linked to certain risks, researchers noted, but new data confirm it is a safe, effective treatment option for patients with severe PR. 

Researchers explored data from nearly 70,000 patients, sharing their findings in the American Journal of Cardiology.

The long-term impact of moderate PPM remains unclear. To learn more, researchers explored dozens of different studies from over the years, sharing their work in the Journal of the American Heart Association.

SCAI and four other major healthcare organizations signed a joint letter in support of intravascular ultrasound.