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New Software Utility Navigating the FDA Database

New Software Utility Makes Navigating the FDA 510(k) Database a Breeze

Applied Medical Market Data’s New Data Analysis Tool Shortens FDA Device Information Searches by 80 Percent

(Amherst, NH) – The rise of rapidly growing economies, particularly in Asia and South America are changing the landscape of the medical device industry. Devices receiving marketing authorization from the U.S. FDA are increasingly being manufactured outside of North America. Understanding this changing landscape is an important success factor in the new product development decision process.

Applied Medical Market Data has developed a program to assist managers in staying current in the 510(k) device space via intuitive screens and simple mouse clicks. Searchable records include all companies and devices in the FDA's 510(k) database. The program consists of a dashboard and supporting tables and charts that allow managers to quickly navigate through FDA 510(k) data, drilling down to more detail when desired, using a number of key aggregators, such as device application, country, approval date, device type and description, supplier, and product code.

The Dashboard also includes maps with zooming and site selection capabilities for visualizing device manufactures spatially by application or product color code. The program takes the almost 58,000 rows/records of approved 510(k) medical devices from 1993 to the present and enables one-click searching and analysis, reducing a task that would normally take hours if not days to one that can be completed in a matter of minutes.

Additional features include:
• color coded spatial map displays of suppliers identifiable with mouse-over ease by country, product code and device application
• device and supplier contact display information
• product listings by supplier, country, product code and product description
• device approvals searchable by country, device application class and product code
• 510(k) approvals by product code, device type and supplier
• time-phased histograms of market approvals by product code, supplier, country and approval year

More information is available at

About Applied Medical Market Data

Applied Medical Market Data assists life science decision makers by providing analysis products and services that can reveal key relationships, patterns and trends affecting their businesses. These information tools encourage opportunity and risk discovery by promoting comprehensive, timely, and insightful analysis, allowing managers to make informed tactical and strategic decisions.

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