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Medical Devices › Clinical Trials › Technology

McDermott Will & Schulte

FDA teases faster approval times with new agency-wide AI tool

McDermott Will & Schulte on

The US Food and Drug Administration (FDA) launched Elsa, a generative artificial intelligence (AI) tool designed to assist FDA employees with tasks such as reading, writing, and summarizing. The press release on the tool’s...more

McDermott Will & Schulte

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

McDermott Will & Schulte on

The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

Foley & Lardner LLP

Protecting Innovations in SaMD & Biomedical Applications

Foley & Lardner LLP on

With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD) is forecasted to grow 16.7% per year over the next decade and surpass $5 billion by 2032....more

Mintz - Health Care Viewpoints

FDA’s Review of Pulse Oximeter Performance Continues a Trend in Addressing Biases in Digital Health Technologies

Mintz - Health Care Viewpoints on

The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and...more

Hogan Lovells

"Make in India" Initiative Extends to Medical Devices - India's New Medical Device Rules Are Now in Effect

Hogan Lovells on

In January 2017, India's Ministry of Health and Family Welfare released the long-awaited Medical Device Rules of 2017 (MDR 2017 or the Act), which took effect on January 1, 2018. Upon implementation, this regulation replaced...more

Knobbe Martens

21st Century Cures Congressional Panel Unveils Medical Technology Proposals

Knobbe Martens on

On January 27, 2015, members of the House Commerce and Energy Committee unveiled a set of legislative proposals aimed at speeding up the development of new medical technology. The 21st Century Cures panel, a bipartisan...more

Searcy Denney Scarola Barnhart & Shipley

FDA Issues Draft Guidance on 510(k)

Searcy Denney Scarola Barnhart & Shipley on

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

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