(Press-News.org) A new article in the February issue of the Journal of the American College of Radiology provides a roadmap for imaging manufacturers to navigate the unique and increasingly complex U.S. regulatory and reimbursement environment. "Evidence Requirements for Innovative Imaging Devices: From Concept to Adoption," identifies and addresses the five phases of an imaging procedure's lifecycle and the distinct clinical evidence needs for each phase.
This article is authored by Richard Frank, MD, PhD, Vice President, Global Clinical Strategy and Policy, General Electric, Donald W. Rucker, MD, Chief Medical Office, Siemens Healthcare USA, Michael A. Ferguson, PhD, Global Director, Clinical Outcomes and Translational Research, Philips Healthcare and Terry J. Sweeney, Sr. Vice President, Corporate Quality and Regulatory Affairs, Philips Healthcare.
"We think there is a critical need for this kind of roadmap, given the current mismatch between the pace of advances and the time required to clear regulatory, reimbursement and adoption hurdles," said Frank. "Only with full adoption does the patient population truly gain access to the benefits of innovation, for example, in reduction of exposure to radiation or increased compliance with screening recommendations and, hence, earlier detection of disease, better outcomes, and reduction in overall cost of healthcare delivery."
The article closely examines the design, regulatory clearance and approval, early adoption, reimbursement, and full clinical adoption of imaging technology.
Although the development of imaging technology is global, the United States has been the largest and most influential adopter of advanced imaging. Therefore, increases in U.S. evidentiary standards may have a global impact on innovation and access to imaging.
"It is our hope that this study will help to foster greater certainty for manufacturers and all stakeholders in navigating the concept-to-adoption pathway so that patients can continue to benefit from these innovative and often life-saving technologies," said Rucker.
"The potential of medical imaging is incalculable, and we need to make sure that the next generation of Americans are able to benefit from transformative imaging technologies in the same ways that we were," added Ferguson. "We believe that the roadmap we have provided is a strong first step to ensuring that manufacturers are able to invest in such watershed technologies and that as a society we are able to achieve this goal."
INFORMATION:
For more information about JACR, please visit www.jacr.org.
To receive an electronic copy of an article appearing in JACR or to set up an interview with a JACR author or another ACR member, please contact Heather Curry at 703-390-9822 or hcurry@acr.org.
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Crop yields from India's first genetically modified crop may have been overemphasized, as modest rises in crop yields may come at the expense of sustainable farm management, says a new study by a Washington University in St. Louis anthropologist.
The study, by Glenn Stone, PhD, professor of anthropology in Arts & Sciences, appears in the March issue of the journal World Development.
In his paper, Stone compares village yields in 2003 and 2007, which conveniently had very similar levels of rainfall. "Cotton yields rose 18 percent with the adoption of genetically modified ...
A study of bound protons and neutrons conducted at the Department of Energy's Thomas Jefferson National Accelerator Facility has allowed scientists, for the first time, to extract information through experimentation about the internal structure of free neutrons, without the assistance of a theoretical model. The result was published in the Feb. 4 issue of Physical Review Letters.
The major hurdle for scientists who study the internal structure of the neutron is that most neutrons are bound up inside the nucleus of atoms to protons. In nature, a free neutron lasts for ...
Drinking excess alcohol during pregnancy can cause fetal alcohol syndrome (FAS) due to the damaging effects of alcohol on a developing baby's brain. Despite its harmful effects, pregnant mothers continue to drink alcohol – up to 3 in every 1000 babies are born with FAS, which causes intellectual disabilities, behavioural problems, growth defects and abnormal facial features. How alcohol causes these effects is unclear, but researching the problem is difficult because of ethical barriers to studying human fetuses. Ulrike Heberlein and colleagues from the University of California ...
WASHINGTON, DC, February 1, 2011 — Native residents of a neighborhood are more likely to move out when immigrants move in, according to new research by three American sociologists.
"Neighborhood Immigration and Native Out-Migration" appears in the February issue of the American Sociological Review. Study authors are Kyle Crowder of the University of North Carolina at Chapel Hill, Matthew Hall of the University of Illinois-Chicago and Stewart E. Tolnay of the University of Washington.
The authors note that for native whites the tendency to leave areas with large and ...
WASHINGTON, DC, February 2, 2011 — While experts often view aggressive behavior as a maladjusted reaction typical of social outcasts, a new study in the February issue of the American Sociological Review finds that it's actually popular adolescents—but not the most popular ones—who are particularly likely to torment their peers.
"Our findings underscore the argument that—for the most part—attaining and maintaining a high social status likely involves some level of antagonistic behavior," said Robert Faris, an assistant professor of sociology at the University of California-Davis. ...
CORVALLIS, Ore. – The air pollution control measures that were put in place in Beijing during the 2008 Olympic Games – if continued – would cut almost in half the lifetime risk of lung cancer for the area's residents from certain inhaled pollutants, a new study concludes.
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The ...
DAVIS -- While experts often view aggressive behavior as a maladjusted
reaction typical of social outcasts, a new University of California,
Davis, study finds that it's actually popular adolescents--but not
the most popular ones--who are particularly likely to torment their
peers.
"Our findings underscore the argument that--for the most
part--attaining and maintaining a high social status likely involves
some level of antagonistic behavior," said Robert Faris, an assistant
professor of sociology at UC Davis.
The study, co-authored by UC Davis sociology professor ...
A new website is launching, and it is dedicated to homes for sale in Farmington Hills MI. It highlights services for retail home buyers and real estate property investors, too. The new website is located at http://www.HomesForSaleInFarmingtonHillsMI.com.
Darrick Scruggs owns the company, and it is a division of My First Michigan Home, which is a piece of his vision of helping so many people find the missing piece of the real estate equation. Scruggs aims to make this division of the company the ongoing answer to people's questions.
He wants to find ways to grow his ...
Fashion Careers College will award scholarships to hopeful contestants of the hit reality television series, America's Next Top Model. The casting call event will be held on Friday, February 18, 2011 from 8:00 a.m. to 12:00 p.m. at NTC Promenade in San Diego, California. FCC is a proud sponsor of the event.
Contestants vying for a spot on the sixteenth cycle of America's Next Top Model will also be given an opportunity to study for a career in fashion at Fashion Careers College. Scholarships will be awarded to all participants of the casting call who are accepted into ...
Charles Blumenkehl, CEO and managing partner of Blue Asset Management LLC announced his company has closed a multi-million dollar non-performing mortgage tranche collateralized residential assets located throughout New Jersey.
According to Charles Blumenkehl, "We are very pleased to have been able to help our sellers liquidate their non-peforming notes, and are excited about the opportunities we have identified within the group." Blumenkehl continued, "The areas these properties are in, and the price points we were able to achieve, will provide a benefit to our investors ...
