knowledge -WSS

knowledge

author：comprehensive 2025-09-10 16:52:52 - browse：49

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： What does generative AI mean for health care? We asked experts
Next article： What the Wegovy shortage looks like for doctors — and for patients

entertainment

Wikipedia

WSS

What causes rare myocarditis in young men after Covid vaccines?

Truvian presents data for its desktop blood

What's changing in Medicare's open enrollment this year?

Female surgeons have lower rates of long

There’s no way to know how good AI health technologies are

Democrats decry new health bill for going easy on private equity

entertainment

knowledge

knowledge

Alkermes shareholders re

Bernie Sanders bashes nonprofit hospitals over their tax breaks

23andMe had bad news about my health. I wish a person had delivered it

Life sciences deals on track to hit lowest point since 2017

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

UnitedHealth’s Q3 profit jumps as medical costs rise more slowly

Medical records are filled with copy

Biogen says it will cut costs by $700 million, slash 1,000 jobs

Hepatitis C has a cure — but many Americans still lack access to it

In the gardens at Boston Children's Hospital, families find sanctuary

entertainment

A fraught question for the kids of Alzheimer’s: Is it coming for us?

What to watch for from Zogenix and Amicus clinical trials

What's changing in Medicare's open enrollment this year?

Device maker Teleflex to acquire urology company for $600M

How doctors’ personal politics affect patients

There’s no way to know how good AI health technologies are

focus

entertainment

Wikipedia

hotspot