Cardiac: Page 5
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Courtesy of Boston Scientific
Boston Scientific’s cardiac rhythm system hits pivotal trial goals
Boston Scientific, which presented the results at the Heart Rhythm Society meeting, expects to receive FDA approval for the system in 2025.
By Nick Paul Taylor • May 21, 2024 -
Courtesy of Johnson & Johnson
J&J posts latest Varipulse data while awaiting FDA review
Johnson & Johnson is chasing Medtronic and Boston Scientific in the U.S. for a share of the rapidly growing pulsed field ablation market.
By Nick Paul Taylor • May 20, 2024 -
Courtesy of Getinge
Getinge to limit US sales of heart devices after FDA safety warning
CEO Mattias Perjos said the action will have “some negative financial impact,” but the total effect will depend on customers' response.
By Nick Paul Taylor • May 16, 2024 -
Courtesy of Abbott
Abbott recalls Heartmate pump after 70 injuries, 2 deaths reported
In the latest notice, which follows a February recall of the device for a separate issue, Abbott took action due to reports of blood leakage and air entrapment.
By Susan Kelly • Updated May 16, 2024 -
Courtesy of Getinge
FDA tells providers to stop using Getinge heart devices
After months of safety concerns, the FDA said Getinge has yet to “sufficiently” address the problems and risks.
By Nick Paul Taylor • May 9, 2024 -
Justin Sullivan via Getty Images
FDA qualifies Apple Watch AFib feature for use in clinical trials
Officials will accept atrial fibrillation data collected by the wearable as a secondary endpoint in studies of cardiac ablation devices.
By Nick Paul Taylor • May 6, 2024
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