Ellume Faces Class-Action Suit After Class I Recall Of COVID-19 Tests

The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.