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medtechdive
10 小时
J&J pauses Varipulse PFA cases in US
The temporary halt to investigate reported neurovascular events comes two months after Johnson & Johnson won FDA approval for ...
medtechdive
15 小时
Beta Bionics, maker of ‘bionic pancreas,’ files for IPO
The Irvine, California-based company makes an insulin pump called the iLet Bionic Pancreas, which was cleared by the Food and ...
medtechdive
1 天
FDA aims to stem AI device bias, boost transparency in draft guidance
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
medtechdive
2 天
Stryker to buy Inari Medical for nearly $5B
Stryker made several small deals last year but lacked a larger acquisition like its nearly $5 billion proposal for Inari ...
medtechdive
1 天
Outset Medical to pay down debt after raising nearly $300M
Stifel analyst Rick Wise said the financing, a combination of private stock placement and new loans, should help the dialysis ...
medtechdive
2 天
FDA posts early alert about safety risk of Medline’s fluid delivery sets
The agency issued the alert as part of a pilot to improve the timeliness of communications about actions it believes are ...
medtechdive
2 天
FDA issues much-anticipated guidance on pulse oximeters
The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin ...
medtechdive
2 天
Shift left today: Electronics procurement visibility for reliable device development
McKinsey data shows that over a 10-year period, supply chain shocks could cost a medical device company 38% of a typical year ...
medtechdive
5 天
FDA closes 2024 with string of early alerts on device safety risks
Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.
medtechdive
6 天
Few medical devices are designed for children. An FDA-Children’s National collaboration ...
Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the ...
medtechdive
5 天
FDA-commissioned review finds no safety concerns linked to tampons
Officials commissioned the independent review in September in response to a study that found tampons may expose users to ...
medtechdive
6 天
Top 10 medtech deals of 2024
Multibillion-dollar buyouts returned last year, led by Johnson & Johnson’s $13.1 billion acquisition of Shockwave Medical.
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