knowledge -WSS

knowledge

author：knowledge 2025-10-02 05:05:44 Page View：85865

Patient treated with Impella in the heart. -- health tech coverage from STAT — 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. Business Wire

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.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Biden report: The neurospychology of memory and aging
Next article： As demand for Covid shots wanes, Moderna seeks its next success

knowledge

Heart attack and stroke risk calculators need revising

AdobeForbusyprimarycarephysicianslikeme,anannualphysicalwitha27-year-oldmaleisablessing.Sincewe’real

CDC recommends RSV monoclonal antibody for infants

Beyfortus,anewRSVmonoclonalantibodySanofiApanelofadviserstotheCentersforDiseaseControlandPreventionu

ChatGPT in medicine: STAT answers readers' burning questions

MikeReddyforSTATArtificialintelligenceisoftendescribedasablackbox:anunknowable,mysteriousforcethatop

H.R. 3 is the wrong path to lower drug costs

Fromleft,Rep.RichardNeal(D-Mass.)speaksasRep.FrankPallone(D-N.J.)andHouseSpeakerNancyPelosi(D-Calif.