3 medical AI systems clear regulatory hurdles

The last two weeks saw market clearances granted in Europe for AI-based software focused on remote patient monitoring, prostate oncology and real-time guidance of coronary stenting.

Company announcements:

Biobeat’s AI-powered remote patient monitoring platform receives a full CE mark (May 4)

Exini Diagnostics receives CE mark clearance for AI-powered quantitative assessment of prostate-specific membrane antigen (May 3)

Abbott’s new coronary imaging platform powered by artificial intelligence launches in Europe (April 26)

Dave Pearson

Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.

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“Now more than ever, we must recognize that our country’s leadership in groundbreaking medical research spurs scientific innovation, improves public health and creates new innovations that save and improve lives nationwide,” Joseph C. Wu, MD, PhD, explained in a statement. 

The technology used to diagnose, treat and manage cardiovascular disease is always evolving, keeping FDA officials quite busy. But have the agency's standards been slipping in recent years? A cardiologist with Cedars-Sinai Medical Center explored that very question.

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.”