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Pharmaceutical Industry › Artificial Intelligence › Manufacturers

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Troutman Pepper Locke

Ready for the Biotech Bounce Back in 2024?

Troutman Pepper Locke on

Heading into 2024, expectations for biotech venture capital (VC) and private equity (PE) investments were low following two lackluster years, but as we wrap up Q1, those expectations have been turned on their head after a...more

Knobbe Martens

Major Med Device Product Developer GE HealthCare Collaborating with Healthcare Providers

Knobbe Martens on

For good reasons, including product safety, quality assurance, development of delivery procedures and instructions, it has been a common practice for medical device companies and innovators to consult with physicians during...more

Foley & Lardner LLP

Recommendations for Managing Cybersecurity Threats in the Manufacturing Sector

Foley & Lardner LLP on

In the hyper-connected era of smart manufacturing, accelerated by “Industry 4.0,” the manufacturing sector is undergoing a digital revolution. By leveraging technologies such as advanced automation, artificial intelligence,...more

Arnall Golden Gregory LLP

FDA Tries to Keep Up: FDA Publishes Two New Items Related to Artificial Intelligence

Arnall Golden Gregory LLP on

FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...more

Knobbe Martens

AI & the FDA

Knobbe Martens on

The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more

Morgan Lewis

AI in Medical Devices and Healthcare: Opportunities, Challenges, and What Lies Ahead

Morgan Lewis on

In recent years, the digitalization of the healthcare industry has been accelerated to meet demands for smarter devices and robotics, wearable technology, AI-based data analysis, and enhanced platforms and simulations, among...more

Akin Gump Strauss Hauer & Feld LLP

FDA Changes Direction in Final CDS Guidance

Akin Gump Strauss Hauer & Feld LLP on

FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more

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