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COVID-19 Report for Life Sciences and Health Care Companies

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....

News

FDA launches list of AI and machine learning-enabled medical devices

Yesterday, the U.S. Food and Drug Administration (FDA) shared online its list of artificial intelligence and machine learning (AI/ML)-enabled devices that are legally marketed in the U.S....

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COVID-19 Report for Life Sciences and Health Care Companies (September 2021)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.

News

After a long and winding road, FDA finalizes much-debated “intended use” rule

On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical...

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COVID-19 Report for Life Sciences and Health Care Companies (August 2021)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....

News

COVID-19 Report for Life Sciences and Health Care Companies (July 2021)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.

News

“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when...

News

COVID-19 Report for Life Sciences and Health Care Companies (June 2021)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.

News

Expedited breakthrough device coverage, “reasonable and necessary” definition delayed until Dec. 15

On May 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released a display copy of a Final Rule (Final Rule) further delaying the effective date of the Medicare Coverage of...

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