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Machine Learning Medical Devices Technology

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Goodwin

Four Steps to Maximize AI Innovation in Medtech

Goodwin on

Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 6, October 2024

Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...more

McDermott Will & Emery

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

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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

Sheppard Mullin Richter & Hampton LLP

Day 1 Notes from the 42nd Annual J.P. Morgan Healthcare Conference

At the first day of the J.P. Morgan Healthcare Conference, “[T]he answer to the ultimate question of life, the universe and everything is 42.” Recognize that famous line? No, it’s not something from ChatGPT, it’s Douglas...more

Foley Hoag LLP

FDA Releases Guidance on Submissions for AI/ML-Enabled Devices

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On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...more

MoFo Life Sciences

The Importance Of Patents For ML-Based Medical Device Inventions

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The use of machine learning (ML) in the medical device field has greatly expanded in recent years, becoming increasingly important to the product offerings of many medical device companies....more

Mintz - Health Care Viewpoints

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

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

MoFo Life Sciences

Five Key Takeaways From FDA’s Transparency Of AI/Ml-Enabled Medical Devices Virtual Workshop

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On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices. The workshop focused on the...more

Rivkin Radler LLP

Smart Speakers Can Monitor Heartbeats

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Researchers from the University of Washington have developed a system that uses smart speakers and machine learning algorithms to monitor heartbeats without the need for physical contact. The system was described in a study...more

Lowenstein Sandler LLP

A Look Ahead: US FDA And Medical Device Regulations In 2021

Lowenstein Sandler LLP on

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

McDermott Will & Emery

US Office of Management and Budget Calls for Federal Agencies to Reduce Barriers to Artificial Intelligence

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On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...more

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