comprehensive -WSS

comprehensive

author：comprehensive 2025-09-30 17:46:35 - browse：5

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： United colonoscopy coverage change 'may cost lives,' doctors say
Next article： Massive project maps cells in human brain in unprecedented detail

focus

WSS

Wellcome Trust names Røttingen as its new CEO

Annovis Bio delivers candor, but not confidence, on Parkinson’s study

STAT readers on older presidents, polypills, Medicare, and more

6 phony surgeries that take placebo to the extreme

Wellcome Trust names Røttingen as its new CEO

How clinical AI models' predictive power can degrade over time

leisure time

comprehensive

focus

Bright Health sells Medicare Advantage business to Molina

Cancer cells are shown to suck energy source from immune cells

Duchenne breakthrough therapy leaves behind pioneering families

Kidney disease boosts cardiac arrest risk for Hispanics, Latinos

Peter Hotez and the public health issue of online harassment

New documents shed light on MD Anderson Cancer Institute feud

In Memoriam: Notable people who died in 2023

With competition flaring, obesity drug hits goal in liver disease study

State Dept. review finds Biden bears some blame for Afghanistan failures

The Harvard botanist who searched for psychedelics in the Amazon

hotspot

Bernie Sanders bashes nonprofit hospitals over their tax breaks

Female surgeons have lower rates of long

Medicare inequities exacerbate Puerto Rico’s health disparities

Readout LOUD podcast: Merger Mondays, Ozempic panic

NIH study of ME/CFS points to clear biological hallmarks

STAT Readout: Today's biotech news includes Sana and Amylyx

focus

focus

explore

knowledge