Navigation Links
Researchers develop outline that may help weigh benefits of new imaging technologies
Date:2/7/2011

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."


'/>"/>

Contact: Heather Curry
hcurry@acr.org
703-390-9822
American College of Radiology / American Roentgen Ray Society
Source:Eurekalert

Related medicine news :

1. Researchers map all the fragile sites of the yeast Saccharomyces cerevisiaes genome
2. UH Case Medical Center researchers publish promising findings for advanced cervical cancer
3. Researchers discover new way to kill pediatric brain tumors
4. Researchers Who Discovered First Genes for Stuttering will Present Findings to the National Stuttering Association
5. Researchers create drug to keep tumor growth switched off
6. Urine protein test might help diagnose kidney damage from lupus, UT Southwestern researchers find
7. GUMC researchers say flower power may reduce resistance to breast cancer drug tamoxifen
8. Clemson researchers develop hands-free texting application
9. Researchers find biomarkers in saliva for detection of early-stage pancreatic cancer
10. Researchers chart genomic map spanning over 2 dozen cancers
11. Researchers discover second protective role for tumor-suppressor
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2017)... ... March 27, 2017 , ... Osteitis pubis may be commonplace ... injury, it occurs when the muscles around the pelvis become inflamed. Over time, ... lower torso, as well as accompanying tenderness and weakness. Without proper intervention, it ...
(Date:3/27/2017)... ... March 27, 2017 , ... EpiGentek , a ... the recent RNA methylation “gold rush” with their established portfolio of optimized assay ... of N6-methyladenosine, or m6A , RNA methylation has received a new burst ...
(Date:3/27/2017)... ... , ... Janet Schloz is still in shock after receiving a $2,500 Academic Award from ... time,” she said. , She thinks the coming week is going to be a very ... have to help my students.” , The award will allow the 4th grade teacher at ...
(Date:3/27/2017)... ... March 27, 2017 , ... Sodium determination is ... complicated and require expert user knowledge. In a live webinar on April 11th ... simplified, yet highly accurate, determination of sodium. , It has long been known ...
(Date:3/27/2017)... ... March 27, 2017 , ... ... Orange facility from 8:00am-10:00am on Monday, April 3rd to commemorate the two-year anniversary ... an opportunity for area-residents to celebrate two great years while also familiarizing themselves ...
Breaking Medicine News(10 mins):
(Date:3/27/2017)... 2017 /PRNewswire/ - INVICTUS MD STRATEGIES CORP. ("Invictus MD" ... MD is pleased to announce it has received conditional ... the TSX Venture Exchange.  Receiving the ... of significant achievements for Invictus-MD. Some of which include: ... AB Laboratories Inc. ("AB Labs"), a Licensed Producer under ...
(Date:3/27/2017)... , March 27, 2017 ... as the NASDAQ Composite closed the trading session up ... and the S&P 500 was down 0.08%. US markets ... sectors finishing the day in green. Pre-market today, Stock-Callers.com ... Medical Group N.V. (NASDAQ: WMGI), Amedica Corporation (NASDAQ: AMDA), ...
(Date:3/27/2017)... March 27, 2017 Cota Healthcare, ... value-based precision medicine, today announced the signing ... Pharmaceuticals Corporation to help improve clinical and ... As part of this agreement, which ... entered into January 2016, teams from across ...
Breaking Medicine Technology: