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FDA clears new computer-assisted device for removing clots in stroke patients

June 12, 2026 - 23:42

FDA clears new computer-assisted device for removing clots in stroke patients

The U.S. Food and Drug Administration has given the green light to a new computer-assisted device designed to remove blood clots in people suffering from strokes. The device, called Thunderbolt, was developed by Penumbra, a medical technology company based in California. It uses a technique known as modulated aspiration, which allows the system to detect a clot and then apply controlled suction to pull it out of the blood vessel.

Stroke is a leading cause of long-term disability, and every minute of delay in treatment can damage brain tissue. The Thunderbolt device is meant to give doctors a more precise and efficient tool for restoring blood flow quickly. By using real-time feedback, the system can adjust its suction power based on the clot's size and density, which may reduce the chance of complications.

The approval comes at a significant time for Penumbra. In January, Boston Scientific announced a deal to acquire the company for about $14.5 billion. That acquisition is still expected to close later this year, pending regulatory approvals. While the Thunderbolt device is now cleared for use in the United States, its long-term impact will depend on how it performs in real-world hospital settings and whether it leads to better outcomes for patients.


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