The Food and Drug Administration (FDA) regulates medical devices in the U.S. to ensure their effectiveness and safety for patients and users. The FDA's Center for Devices and Radiological Health (CDRH) oversees regulating these firms. The FDA must approve every company involved in the manufacturing, packaging, labeling, and/or sale of medical devices sold in the U.S. Electrocardiographs are classified into Class II categories of medical devices in the U.S. These systems are considered as medical devices through the Federal Food, Drug and Cosmetic (FD&C) Act. Diagnostic imaging systems are classified under the category of non-501(k)-exempt Class I and Class II medical devices and do not follow the Pre-Marketing Approval (PMA) pathway by U.S. Food and Drug Administration (FDA). In 501(k) pathways, any new diagnostic imaging devices under Class I and Class II should be legally marketed and should have a clear definition of technological characteristics, applications, and indications.

1. Scope of Research Study 

2. Research Methodology 

3. Industry Outlook

4. Competitive Assessment 

5. Market Dynamics 

6. Global Electrocardiographs Market 

7. Global Electrocardiographs Market (by Product Type) 

8. Global Electrocardiographs Market (by End User)

9. Global Electrocardiographs Market (by Region)

10. Company Profiles