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Johnson & Johnson pauses U.S. rollout of Varipulse device after reports of four serious events.
Johnson & Johnson has temporarily halted the U.S. rollout of its Varipulse pulsed field ablation system after four reported neurovascular events during an external evaluation.
The company is investigating the incidents to ensure safety, while the device has been used in over 3,000 global procedures.
Commercial activities and cases outside the U.S. are not affected.
More details are expected soon.
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Johnson & Johnson detiene el lanzamiento en Estados Unidos del dispositivo Varipulse después de informes de cuatro eventos graves.