GE HealthCare leads with 72 AI-enabled devices; Siemens, Canon, Philips, Aidoc also make top 5

For the third year in a row, GE HealthCare has led the field with 72 artificial intelligence-enabled devices cleared or authorized by the U.S. Food and Drug Administration.

The FDA most recently updated its tally of approved products on May 13 with a total of 882 devices and 191 added in the latest revision. GE recently touted its place at the top of the list, which includes about 60 from the company and others earned by recently acquired firms BK Medical (2), Caption Health (5) and MIM Software (5).

“GE HealthCare is committed to pushing the boundaries of what is possible, utilizing advanced technologies like AI, to help deliver the future of healthcare,” Taha Kass-Hout, MD, chief science and technology officer at Chicago-based GE HealthCare, said in a May 22 announcement.

Most recently, GE acquired MIM Software, closing the deal in April. The Cleveland AI firm offers a suite of solutions that allow physicians to integrate images from multiple modalities into one treatment plan, along with advanced processing to help gauge patients’ response to therapy.

Meanwhile, four other radiology-focused companies also made the top five in approvals:

  1. GE Healthcare: 72
  2. Siemens Healthineers: 64
  3. Canon: 28
  4. Philips: 27
  5. Aidoc: 23

Radiology accounted for the bulk of approvals in the latest FDA update, with 128 of the newly added items related to the specialty. About 150 of the latest approvals were granted between Aug. 1 and March 31 while the other 40 were from previous periods and approved after further refinement, according to the FDA.

Despite the explosion in FDA approvals/clearances in recent years, the Centers for Medicare & Medicaid Services has only assigned payment for about 10 of these AI applications. More than a dozen patient advocacy groups earlier this month urged Congress to address this issue.

Marty Stempniak

Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic. 

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