STAT+: FDA’s warning to J&J’s Abiomed signals a crackdown on digital health tools
The Food and Drug Administration is following through on its promise to regulate more health software tools, starting with a public reprimand of Johnson & Johnson’s heart pump company, Abiomed.
Abiomed, which was bought by Johnson & Johnson late last year for $16.6 billion, sells devices for heart failure patients as well as patient monitoring software. The FDA published a warning letter on Wednesday telling the company it should have submitted its software for approval before putting it on the market. The agency also took issue with Abiomed’s failure to report various problems with its heart pumps.
The letter comes a year after the Food and Drug Administration announced its intention to regulate more health software tools, sending the industry into an uproar. These clinical decision support tools, often powered by artificial intelligence, help doctors understand treatment options or predict patient risk. The FDA has not regulated them, historically. But when the tools don’t work properly, patients are harmed, as shown in STAT’s investigation into a malfunctioning sepsis algorithm developed by Epic.
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