Johnson & Johnson said on Wednesday it has temporarily paused the rollout of its Varipulse heart device in the United States, ...
The temporary pause follows reports of four cases of neurovascular events in the US external evaluation study.
Johnson & Johnson pauses U.S. Varipulse cases to investigate neurovascular events. The FDA-approved device integrates PFA ...
Despite the pause, the company clarified that the suspension does not impact commercial activity outside the US.
FDA grants priority review tag to JNJ's nipocalimab BLA for gMG and asks for new warnings on GSK & PFE's RSV vaccine labels.
In that single-arm study, the rate of primary adverse events within 7 days of ablation was 2.9%, with the most common ...
Johnson & Johnson said on Wednesday it temporarily paused the rollout of its Varipulse heart device in the United States as ...
“On January 5, out of an abundance of caution, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and ...
The temporary pause will allow the company to investigate four neurovascular events seen in an external validation study.
Johnson & Johnson MedTech has temporarily paused all U.S. external evaluations and cases using its Varipulse pulse field ...
Johnson & Johnson halted the limited rollout of its Varipulse pulsed field ablation system on Jan. 5 to “investigate the root causes of four reported neurovascular events in the U.S. external ...
Johnson & Johnson shares are down 3% Wednesday on safety concerns that could dim sales prospects for a new heart device, ...