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16 Aug 2012, 7:17 pm
Jeff Shuren, Director of the Center for Devices and Radiological Health (“CDRH”), expressing their concern “about weaknesses in the premarket review process used to evaluate most medical devices. [read post]
8 Feb 2010, 7:00 am
Last year hundreds of patients at the Cedars-Sinai Medical Center in Los Angeles received up to eight times the normal radiation dose during scans.If you’ve suffered an injury by defective medical equipment, contact an experienced Atlanta, Georgia personal injury attorney immediately. [read post]
31 Jan 2016, 8:39 am
In their suit, plaintiffs named two doctors, Methodist LeBonheur Healthcare, Memphis Vascular Center, and Memphis Radiological, P.C. as defendants. [read post]
1 Dec 2020, 10:27 am
” Discussing the marked rise in mislabeling and fraudulent virus-related products, Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, reminded marketers in a June 17, 2020 press release that “[p]roviding regulatory flexibility during this public health emergency never meant we would allow fraud. [read post]
20 Nov 2020, 4:25 pm
Centers for Disease Control and Prevention (“CDC”) recommended against traveling for Thanksgiving in an Advisory released on November 19. [read post]
6 Aug 2013, 6:03 pm
Report Highlights Concerns About Security Of Sensitive Personal Information Americans Will Share With HHS Exchange Portal AS HHS Invites Consumers To Set Up Personal Accounts The reported finding that the Department of Health & Human Services (HHS) has yet to complete the necessary security arrangements and testing for the web-portal Incomplete security arrangements and testing necessary to ensure the security of personal health and other information shared by consumers on the health… [read post]
19 Feb 2018, 6:00 am
Companies in its portfolio include Cano Health, an operator of “primary care plus” healthcare centers, and Comfort Health, an operator of Medicare HMO and Medicaid healthcare centers. [read post]
8 Jul 2015, 9:20 am
The care he received included “emergency, trauma, intensive care, radiology and vascular surgery specialists. [read post]
13 Sep 2018, 9:30 pm
In a joint statement, FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health Director Jeff Shuren emphasized FDA’s work to “modernize” its regulatory approach in the field of digital health. [read post]
17 Nov 2011, 5:39 am
The first discussion panel centered on Dr. [read post]
31 May 2018, 9:45 pm
Malvina Eydelman of FDA’s Center for Devices and Radiological Health said the device “reduces sensitivity to bright light and glare” and “improves the cosmetic appearance of the eye” in patients with iris defects. [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]
8 Apr 2019, 9:47 pm
A stool specimen collected on March 14 at Legacy Emmanuel Medical Center tested culture positive at Oregon State Public Health Laboratory for shiga toxin-producing E. coli O157 (Case ID#556818). [read post]
9 Jun 2014, 5:56 am
The Staff Handbook began by delineating to whom the Staff Handbook applied: “[A]ll Medical Center employees, other than members of the Faculty. . . . [read post]
17 Feb 2022, 2:58 pm
This might include out-of-network providers who deliver emergency services, radiology, pathology, and obstetrics.While some physician practice groups have the resources to double-check QPAs, research the median rates for “similar” services, and retain skilled legal counsel, many smaller practices will be at a significant disadvantage. [read post]
20 Dec 2017, 7:36 am
Companies in its current portfolio include Harmar, a designer and manufacturer of mobility and accessibility solutions for individuals who use power wheelchairs/scooters or are otherwise mobility impaired; EVP EyeCare, which operates 11 ophthalmology clinics and five ambulatory surgery centers exclusively focused on the treatment of ophthalmic conditions; and Center for Vein Rest [read post]
17 Sep 2009, 6:56 am
Nurses at Ohio State University Medical Center, for example, can insert at least two IV lines a day. [read post]
7 Jul 2020, 10:10 pm
Van Cleve Professor of Law and inaugural director of the university’s Center for the Study of Race, Ethnicity & Equity, will receive the Arthur Holly Compton Faculty Achievement Award. [read post]
28 May 2020, 12:40 pm
This is nearly four times the treatment cost for other common health issues, as per the report of The Mesothelioma Center. [read post]
27 Jul 2014, 9:00 pm
For a list of speakers and to RSVP, visit the Wilson Center website. [read post]
