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Software › Regulatory Reform › Medical Devices

Knobbe Martens

Bipartisan Law Introduced to Clarify Patent Eligibility

Knobbe Martens on

For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries adjacent...more

Wilson Sonsini Goodrich & Rosati

FDA Reduces Regulatory Burden for Certain Medical Image Analyzers

Wilson Sonsini Goodrich & Rosati on

The U.S. Food and Drug Administration (FDA) had regulated medical image analyzers for more than 20 years under the agency’s most stringent regulatory requirements. But the agency recently reclassified a subset of these device...more

Polsinelli

FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend

Polsinelli on

The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more

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