fda
In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said. “Use of this device may cause serious injuries or death,” an FDA notice about the recall said. But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure. In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and r...
Kaiser Health News
In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said. “Use of this device may cause serious injuries or death,” an FDA notice about the recall said. But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure. In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and r...
California Healthline
From his perch in the Trump administration’s Department of Health and Human Services, Roger Severino made a controversial name for himself, working to shield health workers who declined to perform medical procedures including abortion on religious grounds. After President Donald Trump left office, Severino helped the conservative Heritage Foundation develop a plan to expand that conservative stamp to the broader department, recasting HHS with a focus on traditional marriage and family. The vision is outlined in the Project 2025 “Mandate for Leadership,” a blueprint by the foundation and allied...
Kaiser Health News
The Centers for Disease Control and Prevention says a glitch in its bird flu test hasn’t harmed the agency’s outbreak response. But it has ignited scrutiny of its go-it-alone approach in testing for emerging pathogens. The agency has quietly worked since April to resolve a nagging issue with the test it developed, even as the virus swept through dairy farms and chicken houses across the country and infected at least 13 farmworkers this year. At a congressional hearing July 23, Rep. Brett Guthrie (R-Ky.) asked about the issue. “Boy, that rings of 2020,” he said, referring to when the nation was...
Kaiser Health News
The Centers for Disease Control and Prevention says a glitch in its bird flu test hasn’t harmed the agency’s outbreak response. But it has ignited scrutiny of its go-it-alone approach in testing for emerging pathogens. The agency has quietly worked since April to resolve a nagging issue with the test it developed, even as the virus swept through dairy farms and chicken houses across the country and infected at least 13 farmworkers this year. At a congressional hearing July 23, Rep. Brett Guthrie (R-Ky.) asked about the issue. “Boy, that rings of 2020,” he said, referring to when the nation was...
California Healthline
SoniVieは RDNパイロット試験の結果、ラジアルアクセスFIH、FDAのピボタルIDE承認を発...
PR Newswire
Pharmacist Mark Mikhael has lost 50 pounds over the past 12 months. He no longer has diabetes and finds himself “at my ideal body weight,” with his cholesterol below 200 for the first time in 20 years. “I feel fantastic,” he said. Like millions of others, Mikhael credits the new class of weight loss drugs. But he isn’t using brand-name Wegovy or Zepbound. Mikhael, CEO of Orlando, Florida-based Olympia Pharmaceuticals, has been getting by with his own supply: injecting himself with copies of the drugs formulated by his company. He’s far from alone. Mikhael and other industry officials estimate ...
Kaiser Health News
最終段階の主軸となる検証試験である2つの第III相臨床試験の実施計画書についてFDAの承諾を取得第I...
PR Newswire
In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.” In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has compared it to “landing a man on the moon.” MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ...
Kaiser Health News
In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.” In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has compared it to “landing a man on the moon.” MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ...
California Healthline
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