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22 May 2024, 7:07 pm
Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert —We recently blogged about the Center for Devices and Radiological Health’s (CDRH) reluctance to make full use of real-world data (RWD) and real-world evidence (RWE) to support marketing applications. [read post]
21 May 2024, 8:30 am
Additional FDA Guidance At the May 14 webinar, FDA announced that the Center for Devices and Radiological Health will host a series of webinars to clarify different aspects of its phaseout policy. [read post]
13 May 2024, 2:49 pm
As a preliminary matter, it is worthwhile to highlight that this risk is captured in the Human-Centered core principle and, more broadly, 600-1 is properly viewed as part of the Governance core principle. [read post]
10 May 2024, 2:31 am
Take, for example, radiology. [read post]
26 Apr 2024, 12:48 pm
” Kim also is the co-director of Washington University’s Center for Empirical Research in the Law. [read post]
7 Mar 2024, 8:00 am
He was rushed to Westchester Medical Center where he underwent a head CT scan and had a neck CTA. [read post]
15 Feb 2024, 9:01 pm
It is already being used for call centers, account openings, compliance programs, trading algorithms, sentiment analysis, and more. [read post]
8 Feb 2024, 10:00 pm
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first step as the agency prepares to oversee laboratory-developed tests (LDTs). [read post]
8 Feb 2024, 10:00 pm
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first step as the agency prepares to oversee laboratory-developed tests (LDTs). [read post]
8 Feb 2024, 10:00 pm
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first step as the agency prepares to oversee laboratory-developed tests (LDTs). [read post]
8 Feb 2024, 10:00 pm
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first step as the agency prepares to oversee laboratory-developed tests (LDTs). [read post]
8 Feb 2024, 10:00 pm
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first step as the agency prepares to oversee laboratory-developed tests (LDTs). [read post]
8 Feb 2024, 10:00 pm
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first step as the agency prepares to oversee laboratory-developed tests (LDTs). [read post]
5 Feb 2024, 2:04 pm
A qui tam whistleblower spurred an investigation that found that two radiology practices, Radiation Therapist Associates, P.C. [read post]
4 Feb 2024, 6:46 pm
Mullen —On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). [read post]
11 Dec 2023, 8:33 pm
FDA’s 5-year average across all of CDRH is 73 PMAs, PDPs, Panel-Track PMA Supplements; 3,877 510(k) premarket notifications; and 66 de novo submissions per year.[7] This means that OHT7, the Division responsible for reviewing in vitro diagnostic tests, will need to be staffed to review substantially more submissions per year than the entire Center, specifically: 57 times the number of PMAs, PDPs, Panel-Track PMA Supplements; 8 times the number of 510(k) premarket… [read post]
9 Nov 2023, 3:55 am
However, the Order provides a specific roadmap, and players in the AI industry should take note of its multitude of provisions centered on safety, security and trust and position themselves accordingly. [read post]
6 Nov 2023, 9:12 am
It gives the Department of Homeland Security (DHS) a sprawling remit to address the potential for AI to create chemical, biological, radiological, and nuclear (CBRN) threats. [read post]
5 Nov 2023, 7:32 pm
Won’s career path included a tenure at FDA’s Center for Devices and Radiological Health (CDRH), Division of Dental and ENT Devices within the Office of Product Evaluation and Quality. [read post]
31 Oct 2023, 6:26 am
Pix Credit here My Administration places the highest urgency on governing the development and use of AI safely and responsibly, and is therefore advancing a coordinated, Federal Government-wide approach to doing so. [read post]
