AuntMinnie
FEBRUARY 1, 2024
“Transparency is the degree to which appropriate information about a device – including its intended use, development, performance, and, when available, logic – is clearly communicated to stakeholders,” the group wrote.
MRI Network
MARCH 27, 2025
The number of machine learning- and AI-powered medical devices approved by the U.S. In 2024, the FDA approved nearly 1,000 AI medical devices compared to just 221 in 2023. At the same time, there are concerns about whether the FDA has approved some medical devices too quickly.
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AuntMinnie
MARCH 4, 2025
Philips 's Image Guided Therapy Services division has sent out an urgent medical device recall letter for its Tack Endovascular System, according to a March 3 announcement from the U.S. The FDA is classifying this recall as the "most serious type," noting that the device can "cause serious injury or death."
Radiology Business
FEBRUARY 25, 2025
The New York-based healthcare AI firm has scored U.S. Food and Drug Administration clearance for its Ezra Flash, a class 2 medical device.
AuntMinnie
NOVEMBER 18, 2024
With strong demand for medical imaging in many differing clinical contexts, hospitals are managing growing routine imaging demands while balancing teaching practices, ambulatory services, primary care, and subspecialty services. billion healthcare facility. Another, a new hospital complex is underway at University of Utah Health.
AuntMinnie
MAY 14, 2024
Centers for Medicare and Medicaid Services (CMS) to establish a formalized payment pathway for AI healthcare services. Currently, CMS has only assigned payment for less than 10 AI applications, compared with the 600 plus AI-enabled medical devices that the U.S.
Imaging Technology
NOVEMBER 15, 2023
(USEI), a reputable medical device manufacturing company with over 25 years of experience announced it has been acquired by Intellectt, Inc., as it expands its capabilities in the healthcare industry with its 7th acquisition in the Life Science/Healthcare sectors within the prior two years. Intellectt, Inc.
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