No Password Required: CEO of HACKERverse.ai, Disruptor of Cybersecurity Sales and Most Other Things
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FCPA Compliance Report: Upping Your Game in Compliance
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Creativity and Compliance: From Compliance Enforcers to Trusted Advisors: The Path Forward
Compliance and AI: Navigating Regulatory Challenges in 2025 with Allison Lagosh
Top Healthcare Compliance Priorities for 2025
Joe Green & Monica Rodriguez Kuniyoshi on Integrating Generative AI with Your Experts - Passle CMO Series Podcast RE-RELEASE:
Innovation in Compliance: Exploring the Intersection of Compliance, Technology, and AI with Ben Sperry
Harnessing the Power of eDiscovery: The Revolution of AI and Technology in Litigation and Investigations - The Consumer Finance Podcast
CMO Series Podcast RE-RELEASE: Tracey Whyte on Getting The Most Out of AI in a Lean Marketing and BD team
AI Legislation: The Statewide Spotlight - Regulatory Oversight Podcast
Compliance Tip of the Day: Standing at the Turning Point
Compliance Tip of the Day – Role of Chatbots in Compliance
AI Legislation: The Statewide Spotlight — The Consumer Finance Podcast
Compliance Tip of the Day – AI and Behavioral Analytics
Key Discovery Points: Don’t Rush in as an AI Fool!
100 Days In: What Employers Need to Know - Employment Law This Week® - #WorkforceWednesday®
5 Key Takeaways | AI and Your Patent Management, Strategy & Portfolio
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more
Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial...more
For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more
Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a record high of 221 last year, according to data tracing back to 1995....more
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
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
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
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
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
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
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
Last week, the FDA issued a warning against the use of robotic surgery for mastectomy and other cancer-related procedures. ...more
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