News & Analysis as of

Food and Drug Administration (FDA) FDA Approval Artificial Intelligence

Epstein Becker & Green

Unpacking Averages: Is It Too Soon to Study the Postmarket Experience of AI-Driven Medical Devices?

I may be jumping the gun here, but I’m anxious to understand how the new flurry of AI medical devices is performing in the marketplace, or more specifically, whether the devices are failing to perform in a way that...more

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

Polsinelli on

Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

Arnall Golden Gregory LLP

[Webinar] FDA Tries to Keep Up: How FDA and Industry Are Trying to Keep Up With Artificial Intelligence - September 13th, 2:00 pm...

FDA has cleared or approved hundreds of products that work with artificial intelligence (“AI”) and acknowledges that the agency and industry need help navigating how FDA-regulated products engage with AI. In response to the...more

Knobbe Martens

FDA Clears Sonic DL™ for Cardiac MRI Scans

Knobbe Martens on

On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™.  GE HealthCare reports that Sonic DL™ is a deep learning-based technology intended to capture cardiac MRI images within a single heartbeat....more

Goodwin

FDA Issues Draft Guidance for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

Goodwin on

The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

Mintz

COVID-19: Prioritized Patent Application Examination and Patents 4 Partnerships

Mintz on

The United States Patent and Trademark Office (USPTO) has recently launched two new initiatives to support COVID-19 innovations: 1) a COVID-19 Prioritized Examination Pilot Program, and 2) Patents 4 Partnerships that provides...more

Foley & Lardner LLP

Manufacturing MarketTrends - July 2019, Issue 2

Foley & Lardner LLP on

Welcome to issue two of Foley’s Manufacturing MarketTrends newsletter, which highlights key trends with the potential to make 2019 a year of change for manufacturers. In this issue, we will explore collaboration between the...more

Shook, Hardy & Bacon L.L.P.

The FDA’s Latest Warning: A Good Reminder Regarding the Litigation Risks of Off-Label Use

Last week, the FDA issued a warning against the use of robotic surgery for mastectomy and other cancer-related procedures. ...more

Knobbe Martens

FDA grants De Novo Market Clearance of Artificial Intelligence Software

Knobbe Martens on

According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO Stroke Platform. According to PR Newswire, Viz.AI’s LVO Stroke Platform is the...more

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