“It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA,” according to the warning letter. These issues, the agency added, “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.”

Kenneth Ellenbogen, MD, detailed some of the biggest trends he saw at the three-day event in New Orleans. 

There are now numerous AI algorithms for electrophysiology. Jagmeet Singh, MD, examined how this advanced technology is being applied.

The newly approved device is powered by Bluetooth technology and available with a three- or six-year battery.

Samsung's smartwatches, already equipped with ECG technology, will now be able to alert users when signs of an irregular heart rhythm are detected. 

Click through a series of photos of cardiology-related technologies from the world's largest health IT conference.

Casana, the company behind the Heart Seat, is now pursuing approvals for additional indications. 

The new-look device, which captures ECG and seismocardiogram measurements at the same time, is completely wireless and runs on batteries that last up to 40 hours.