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Class Action FDA Approval Medical Devices

A class action is a type of legal action where a representative individual or group of individuals can bring a claim on behalf of a larger group or class who share a common legal interest.
Benesch

Dialysis & Nephrology Digest - June 2025

Benesch on

Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more

Goodwin

Securities Litigation Against Life Sciences Companies 2024 Year in Review

Goodwin on

Welcome to our ninth annual report on US securities class actions filed against publicly traded life sciences companies, which include pharmaceutical, biotechnology, medical device, and healthcare companies....more

Perkins Coie

Ninth Circuit Rejects Securities Fraud Thesis That Did Not “Make a Whole Lot of Sense”

Perkins Coie on

In its June 10, 2020, opinion in Nguyen v. Endologix, the U.S. Court of Appeals for the Ninth Circuit applied the plausibility standard to a plaintiff’s securities fraud claims and affirmed the district court’s dismissal,...more

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