A US Food and Drug Administration (FDA) advisory panel struggled to muster support for marketing clearance of the TriGuard 3 (Keystone Heart) device for use during transcatheter aortic valve ...
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June 18 (Reuters) - EnteroMedics Inc's shares jumped about 37 percent in premarket trading on Wednesday, a day after an advisory panel to the U.S. Food and Drug Administration voted in favor of the ...
(Reuters) -A panel of advisers to the U.S. Food and Drug Administration (FDA) on Tuesday recommended the use of a device made by a unit of Otsuka Holdings in a type of surgery to treat high blood ...
When the Food and Drug Administration recently convened a committee of advisers to assess a cardiac device made by Abbott, the agency didn’t disclose that most of them had received payments from the ...
Please provide your email address to receive an email when new articles are posted on . An FDA panel voted that the benefits of a transcatheter edge-to-edge repair device outweigh risks in severe ...
LEXINGTON, Mass., April 27, 2022 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today ...
GAITHERSBURG, Md., Nov 4 (Reuters) - A U.S. panel of medical experts on Wednesday recommended against wider use of a Zimmer Holdings Inc spine stabilization device, questioning the company's data but ...
FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland (Reuters) -The U.S. Food and Drug Administration's (FDA) independent experts on Wednesday narrowly voted against ...
Please provide your email address to receive an email when new articles are posted on . A panel of expert glaucoma surgeons reached consensus on patient selection and preoperative, perioperative and ...
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(Reuters) -The U.S. Food and Drug Administration's (FDA) independent experts on Wednesday narrowly voted against recommending the approval of Medtronic's blood pressure treatment device, saying risks ...