SaMD US Market Access_Infographic-01.pdf

The infographic provides insights into the Software as a Medical Device (SaMD) regulatory landscape in the United States.

SaMD Approvals in US Market Over the Years

A line graph shows the number of annual SaMD approvals by the US FDA from 1995 to 2024.

Approvals remained low and inconsistent until 2015, with numbers generally in single digits or low teens.

From 2016 onwards, approvals rose significantly, peaking at 130 approvals in 2023.

By 2024, the total approvals reached 603.

SaMD Approvals by Therapy Areas

A pie chart highlights the distribution of approvals across therapy areas.

Radiology dominates with 64.34%, followed by Cardiovascular (12.11%), Neurology (4.81%), General Hospital (3.81%), and other areas like Clinical Chemistry, Dental, Hematology, and Ophthalmic each contributing smaller shares.

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SaMD Regulatory Scenario for US

US Market over the years

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SaMD Approvals by Therapy Areas.

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