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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....

News

FDA warns over use of robotically-assisted surgical devices

Last week, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind patients and health care providers that the safety and effectiveness of...

News

Life sciences and health care horizons 2021

Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...

Published Works

Bad News for Device Sponsors: Panel Meetings were Already Going the Way of the Homework Assignment, and COVID Might "Put the Nail in the Coffin" Food and Drug Law Institute

Counsel Kristin Zielinski Duggan and associate Sandra Milena McCarthy co-authored an article published by the Food and Drug Law Institute.

Hogan Lovells Publications

Helping companies navigate the COVID-19 pandemic

Our Medical Device and Technology team has been at the forefront of the COVID-19 legal response since the pandemic swept across the globe. In just a few short months, our team has taken on...

News

FDA loosens restrictions on gynecologic power morcellators, recommends use only with containment

The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an...

News

Guidances galore: FDA finalizes multiple digital health guidance documents

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released a series of guidance documents addressing the agency's current views on software regulation...

News

Guidances galore: FDA finalizes multiple digital health guidance documents

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released a series of guidance documents addressing the agency's current views on software regulation...

News

FDA’s new decision tree for medical device PMAs and De Novos accompanies final uncertainty guidance

On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk...

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