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Goodwin

Life Sciences Licensing and M&A Update: Catching Up on Recent Decisions Affecting Commercially Reasonable Efforts Definitions and...

Goodwin on

Recently, the Delaware Chancery Court and the Third Circuit issued three significant decisions on key issues affecting licensing and M&A transactions in the life sciences industry....more

Gardner Law

From Discretion to Regulation: FDA's New Path for LDTs

Gardner Law on

Earlier this year, we reported on the expected U.S. Food and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs. On May 6, 2024, the...more

King & Spalding

FDA Publishes White Paper on Artificial Intelligence & Medical Products

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On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more

Mintz - Health Care Viewpoints

FDA Faces Critical Deadlines in 2024, Even Without an Election Looming

The American public knows that 2024 is a critical election year, with the next race for the presidency in November expected to be another face-off between President Biden and former President Trump. What the majority may not...more

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

ArentFox Schiff on

Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more

Foley & Lardner LLP

The Health AI Frontier: New Opportunities for Innovation Across the Health Care Sector

Foley & Lardner LLP on

With the health care industry under pressure to improve patient outcomes while controlling costs, artificial intelligence (AI) and machine learning (ML) are quickly becoming indispensable tools. These technologies show...more

King & Spalding

MDD Certificates Remain Valid: European Commission Proposes Longer Transition Periods for MDR Compliance

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On Friday, January 6, 2023, the European Commission adopted a proposal to give more time to certify medical devices in hopes of mitigating the risk of shortages in the European Union (EU). The proposal introduces a longer...more

Jackson Lewis P.C.

FDA Names First Acting Director Of Medical Device Cybersecurity

Jackson Lewis P.C. on

The U.S. Food and Drug Administration (FDA) named University of Michigan Associate Professor Kevin Fu Acting Director of Medical Device Security in its Center for Devices and Radiological Health. This is a newly created...more

King & Spalding

Court Dismisses Shareholder Suit Seeking To Recover Stock Drop from FDA Nonapproval of Experimental Drug

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Companies that sell products or services that cannot be marketed without regulatory preclearance, and particularly companies that develop experimental drugs and medical devices, should take note of the recent opinion by Judge...more

Skadden, Arps, Slate, Meagher & Flom LLP

Hong Kong Regulatory Update - July 2020

This update provides an overview of key regulatory developments in the past three months relevant to companies listed, or planning to list, on The Stock Exchange of Hong Kong Limited (HKEx), and their advisers. In particular,...more

Knobbe Martens

Philips Acquires Spectranetics for $2.16 Billion

Knobbe Martens on

According to a June 28, 2017 press release, Dutch healthcare company Philips has agreed to buy Colorado Springs-based Spectranetics Corporation, a cardiac device manufacturer, for approximately 1.9 billion euros ($2.16...more

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