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9 Jun 2022, 6:00 am
In particular, the measure suggests a way to solve a conundrum at the center of cybersecurity policy: how to translate a general statutory or common law mandate to provide “reasonable” security into specific, technically sound controls. [read post]
1 Dec 2018, 9:00 am
See some of our prior posts: How substance abuse treatment centers navigate anti-kickback rules Substance abuse treatment centers must steer carefully when sending patients for labs. [read post]
15 Apr 2020, 6:38 am
“In diagnostic tests in particular, it’s very difficult to know if something is failing,” said Alberto Gutierrez, former director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. [read post]
8 Sep 2019, 7:00 am
-centered vision has prevailed. [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]
29 Nov 2017, 2:18 am
Radiology and certain other imaging services. [read post]
31 Oct 2017, 11:23 pm
For example: The Centers for Medicare Services (CMS) defines telemedicine as the provision of clinical services to patients by practitioners from a distance via electronic communications. [read post]
7 Nov 2007, 8:28 pm
., director of the Center for Devices and Radiological Health: Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety. [read post]
28 Sep 2013, 11:08 am
See generally Federal Judicial Center, Reference Manual on Scientific Evidence, at 643 n. 28 (3d ed.2011). [read post]
15 Jan 2018, 3:11 am
On the issue of tax affecting, and relying on the oft-cited decision by then-Vice Chancellor Strine in MRI Radiology v Kessler, VC Glasscock agreed with the Petitioner that the operating companies’ status as S corporations “adds value beyond that of a Delaware C corporation. [read post]
4 Jun 2015, 10:02 pm
We can classify them into four broad categories, such as chemical, physical, biological and radiological (thanks to Fukushima). [read post]
15 Apr 2022, 8:21 am
The reservation, which also played a role in the Cold War, was decommissioned in 1989 and is being cleaned and remediated, in substantial part by the contract workers that are at the center of the case. [read post]
26 Jul 2011, 5:26 pm
Newberger – On July 27, 2011, the Center for Devices and Radiological Health ("CDRH") announced the issuance of a Draft Guidance titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device. [read post]
30 May 2020, 7:53 am
Emergency use authorizations are issued for health conditions resulting from Chemical, Biological, Radiologic, and Nuclear (CBRN) threats. [read post]
14 Aug 2024, 5:53 am
AI predictions are not like lab tests and radiology studies and they do not require the same kind of clinical consideration possessed by physicians. [read post]
12 Sep 2010, 10:56 am
(o) "X-ray or imaging services" shall mean diagnostic imaging techniques which shall include but not be limited to the following: (1) conventional x-ray or radiology; (2) fluoroscopy; (3) digital radiography; (4) computed tomography; (5) magnetic resonance imaging; (6) nuclear imaging; (7) ultrasonography; and (8) angiography. [read post]
15 Mar 2018, 9:44 am
He was assassinated in 2006 by a dose of polonium, the radiological signature of which was traced back across the continent to Russia. [read post]
1 Oct 2013, 11:41 am
At the start of Open Enrollment, watch for media advisories for the Centers for Medicare & Medicaid Services’ regular operational updates for reporters. [read post]
26 Sep 2008, 8:03 pm
., Director of FDA’s Center for Radiological Health (“CDRH”), provided a comprehensive overview of current medical device DTC regulation for the Committee. [read post]
25 Oct 2018, 3:34 pm
The partnership between FDA and the DHS In parallel with the release of the draft guidance, FDA issued a news release announcing a new memorandum of agreement between the FDA’s Center for Devices and Radiological Health (CDRH) and U.S. [read post]
