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Boston Sci, Stryker Prevail In Long-Running Suits

 
• By Elizabeth Orr

Two closely watched device-world intellectual property cases moved toward a conclusion last week, as Boston Scientific triumphed over Edwards in a TAVR suit and Zimmer was ordered to pay $254m for infringing Stryker’s patent on a surgical-cleaning wand.

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December has been a busy month for device industry patent law, with two major cases moving closer to a resolution in recent days.

The first case, Stryker v. Zimmer, began with a clash over a surgical-cleaning wand and turned into a debate over...

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FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 
• By Brian Bossetta

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.

FTC Blocks Edwards Lifesciences’ Merger With JenaValve

 
• By Elizabeth Orr

The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.

Trump Taps Food And Drug Law Outsider For FDA Chief Counsel

 
• By Sarah Karlin-Smith

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
• By Elizabeth Orr

A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.

More from Policy & Regulation

NeuroOne Prepares To Launch Trigeminal Nerve Ablation System

 
• By Elizabeth Orr

The US FDA has cleared NeuroOne's OneRF trigeminal nerve ablation system for the treatment of trigeminal neuralgia. This minimally invasive method utilizes radio frequency energy to alleviate pain, offering an alternative to traditional medications and surgeries. A fall commercial launch is planned.

Warning Letters - July 2025

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Nyxoah Launches FDA-Cleared Genio System For OSA As Rival Inspire Files Patent Suit

 
• By Marion Webb

After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.