Explore more Categories
Artificial Intelligence involves the science and engineering of developing intelligent machines
The manufacturing world is at a cusp of a new revolution that will redefine conventional business models
IoT will have a major impact on businesses and consumers in the future
The world is creating 2.5 exabytes of data daily
Our research seeks to connect-the-dots across multiple trends
Personal Robots are Set to Be a $19 Billion Market
Strategic Analysis of BREXIT and its Implications to Industries, Economies and Societies
Time for a Digital Revolution in the Women’s Health Market
iFrost is a digital platform for interactive and dynamic reporting of data.
The TOEs are a great source of information which gives corporates critical information on companies to action for their strategic investments either as an open source platform or to collaborate and to develop successful products
Unchanged Regulatory Process for DXA-BMD Device Approval Makes it Easier for Market Adoption
save 25 %
* Required Fields
Pay by invoice
This study carries Frost & Sullivan’s observation of bone mineral density solutions in select Asian Countries (Australia, South Korea, and China); the regulatory trends for the same have been covered, highlighting the following:• Product registration and regulatory approval process details in select Asian countries (such as the Therapeutic Goods Advertising (TGA) approval for Australia, the China Food and Drug Administration (CFDA) approval for China, and the Ministry of Food and Drug Safety (MDFS) approval for South Korea)• Regulatory requirements for product registration for the DEXA-BMD device in Australia, China, and South Korea (including preclinical amendments, new clinical trials requirements according to country-specific and beta-testing documents, and device classification documentation) o During the country approval and product registration process, the original equipment manufacturer (OEM) need to submit the product clinical evaluation summary reports of the BMD device to verify the safety and performance of the DXA-BMD products, along with the technical file documentation or design dossiers, to the regulatory bodies.• Phantom testing, including the calibration and quality check for the DEXA-BMD device in evaluating the accuracy levels for targeted compositions (spine, lumbar, and peripheral) o When performing BMD testing with DXA systems, a quality analysis program is required to be implemented for guaranteeing any observed density changes and to validate that the changes are real and are not due to machine or operator variability.• Prevalence of osteoporosis and fracture incidence data in the respective countries (Australia, China, and South Korea)• Recommended Young Adult Mean (YAM) for bone mineral density in the countries of Australia, China, and South Korea
Key Issues Addressed
Author: Srikanth Kompalli
Artificial Intelligence for Medical Image Analysis—Companies-to-Action, 2018
Digital Radiography Market in Germany, Forecast to 2021
Global Computed Tomography Market, Forecast to 2021
Italy's New Business Models in Medical Imaging, Forecast to 2021
Developments in Image-Guided Therapy, Forecast to 2020
Global Interventional X-Ray Market, Forecast to 2021
China Medical Imaging Equipment Market, Forecast to 2021
European Congress of Radiology Conference Coverage, 2017
Digital and Computed Radiography in Thailand, Indonesia, and Malaysia, Forecast to 2021
Analysis of the United States Molecular Imaging Equipment and Radiopharmaceuticals Market, Forecast to 2023
wireless charging market
smart lighting market
digital signage market
activated carbon market
tobacco industry analysis
commercial uav market
thermal spray coatings market
Don't have an account? Create One!
Enter your Email Address here to receive a link to change password.
If you are an existing frost.com user, please register using the same email for seamless access
Already have an account? Login!
Use your Linkedin account to login or register within our store.You're just one click away.