FDA Approves First Drug to Image Tau Pathology in Patients …
网页2020年5月28日 · Today, the U.S. Food and Drug Administration approved Tauvid (flortaucipir F18) for intravenous injection, the first drug used to help image a distinctive characteristic of Alzheimer’s disease...
FDA approves imaging drug for evaluation of myocardial ischemia
网页3 天之前 · The U.S. Food and Drug Administration has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia (cardiac...
FDA Clears First Major Imaging Device Advancement for …
网页2021年9月30日 · Today, the U.S. Food and Drug Administration cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade.
FDA has now cleared 700 AI healthcare algorithms, more than …
网页2023年12月13日 · In October 2023, the FDA said it had approved an additional 171 new AI and machine learning (ML) systems just the past year. Medical imaging makes up the majority of FDA-cleared AI algorithms
FDA approves GE HealthCare's flurpiridaz F-18 PET radiotracer for …
网页2 天之前 · The U.S. Food and Drug Administration (FDA) has granted a long-awaited approval to flurpiridaz F-18, GE HealthCare's first-of-its-kind positron emission tomography (PET) myocardial perfusion imaging radiotracer, …
Fresh from the biotech pipeline: record-breaking FDA approvals
网页2024年2月26日 · The US Food and Drug Administration (FDA) approved a record-breaking 71 new medicines in 2023. There were one or two controversial decisions and a slight drop in first-in-class approvals.
GE HealthCare announces FDA approval of Flyrcado (flurpiridaz
网页2 天之前 · GE HealthCare’s FDA-approved flurpiridaz F 18 PET radiotracer, Flyrcado, delivers higher diagnostic efficacy in patients with known or suspected coronary artery disease (CAD), compared to SPECT...
Radiology ‘Game-Changer’: FDA Approves PET Agent for …
网页2 天之前 · The Food and Drug Administration (FDA) has approved Flyrcado™ (flurpiridaz F 18, GE HealthCare), a positron emission tomography (PET) myocardial perfusion imaging (MPI) agent that may enhance the detection of coronary artery disease (CAD) and facilitate expanded access to PET imaging for patients.
How FDA Regulates Artificial Intelligence in Medical Products
网页2021年8月5日 · For example, a report examining companies’ public summaries about their FDA-approved AI tools found that, of the 10 products approved for breast imaging, only one included a breakdown of the racial demographics in …
The state of artificial intelligence-based FDA-approved ... - Nature
网页2020年9月11日 · The medical field of radiology is the trendsetter regarding FDA-approved medical devices and algorithms, with the introduction of AI/ML-based solutions for worldwide applied image reading...
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