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Food and Drug Administration (“FDA”) has announced plans to create a centralized digital health unit within the Center for Devices and Radiological Health (“CDRH”), further supporting CDRH’s 2016-2017 vision to establish a more robust national evaluation system for medical devices. [read post]
11 Mar 2017, 12:59 pm by Schachtman
,” (Sept. 21, 2006); Steven Silverman, Director, Office of Compliance, Center for Devices and Radiological Health, “Warning letter to Dr. [read post]
3 Feb 2017, 3:34 pm by Daily Record Staff
Missoi, M.D. have joined the department of radiology at Mercy Medical Center. [read post]
30 Jan 2017, 3:02 am by Walter Olson
Joseph’s Regional Medical Center case, Stephen Miller/IGF] Study: states with stronger physician protection from malpractice suits had lower usage of imaging tests [Radiology Business on Suhui Li et al., Journal of the American College of Radiology] Hospitals that require employees to take flu shots to protect patients and others may pay dearly if they’re stingy with the religious exemptions [Jon Hyman] “Maybe For-Profit Hospitals Aren’t So… [read post]
21 Dec 2016, 7:36 am by Jay
  The researchers interviewed 19 different radiologists at an urban academic medical center. [read post]
Background The final guidance describes the factors that the Center for Devices and Radiological Health (“CDRH”) will evaluate when deciding whether to alert the public about new adverse events and risks associated with a medical device, referred to as “emerging signals. [read post]
14 Dec 2016, 2:07 pm by James Hoffmann
Another estimate by Centers for Disease Control and Prevention (CDC) shows that nearly 2,000 American workers suffer a work related eye injury requiring medical treatment each year. [read post]
8 Dec 2016, 9:31 am by Neumann Law Group
 The director of the FDA’s center for devices and radiological health recently wrote on the agency’s website that these types of problems are widespread. [read post]
Jeffrey Shuren, Director of the FDA Center for Devices and Radiological Health (CDRH). [read post]
2 Nov 2016, 4:57 am by Amber Walsh
Healthcare companies in its current portfolio includes Physicians Endoscopy, a national developer, owner, and manager of endoscopic surgery centers. [read post]
12 Aug 2016, 12:34 pm by Laura Ray
Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) recently issued a final guidance document General Wellness:  Policy for Low-Risk Devices. [read post]
7 Jul 2016, 9:19 pm
" Contents include:Vincent Bernard, A price too high: rethinking nuclear weapons in light of their human cost After the atomic bomb: Hibakusha tell their stories Tomomitsu Miyazaki, The view from under the mushroom cloud: The Chugoku Shimbun newspaper and the Hiroshima Peace Media Center Akitoshi Nakamura, Photo gallery: Ground zero Nagasaki Seventy years after Hiroshima and Nagasaki: Reflections on the consequences of nuclear detonation Hans M. [read post]
30 Jun 2016, 12:28 pm by Jay
” (ACR Appropriateness Criteria, Suspected Spine Trauma, American College of Radiology (1999, rev. 2012).) [read post]
27 Jun 2016, 6:30 am by Jacob Lazarovic, M.D.
 Rigorous studies of sufficient sample size, using validated clinical, radiological and biomechanical measures and tissue injury healing response biomarkers are needed to determine long-term effectiveness and safety. [read post]
17 Jun 2016, 5:30 am by Kori Shafer-Stack
From 2007 to 2013 for claims at 12 months of experience, we observed little change on average in the number of visits for major radiology services by nonhospital providers. [read post]
  The draft guidance implements a December 2015 Memorandum of Understanding between FDA’s Center for Devices and Radiological Health (CDRH) and CMS’s Coverage and Analysis Group (CAG) to streamline and facilitate the efficient categorization of investigational medical devices in order to support CMS’s ability to make its reimbursement determinations. [read post]