Cardiac: Page 4
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Courtesy of Edwards Lifesciences
Edwards to acquire Innovalve, stake in Affluent Medical
The heart valve specialist said in a federal filing that it expects to pay $300 million in cash for Innovalve Bio Medical when the deal closes.
By Susan Kelly • July 15, 2024 -
Permission granted by Boston Scientific
PFA devices are changing AFib treatment. The next wave could grow the market further.
New pulsed field ablation systems from Boston Scientific and Medtronic are already reshaping the cardiac ablation market, but upcoming devices could spur even greater adoption.
By Susan Kelly • June 17, 2024 -
Explore the Trendline➔
Sarah Silbiger via Getty Images
TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
Fotolia
Kardium raises $104M to develop pulsed field ablation system
Kardium will use the funding to complete a clinical study for pursuing regulatory approvals and build its manufacturing, clinical support and commercial teams.
By Susan Kelly • June 12, 2024 -
Sarah Silbiger via Getty Images
Abbott issues recall for Heartmate system monitor
Abbott’s heart pump system and related products have been part of multiple Class I recalls this year.
By Susan Kelly • June 11, 2024 -
Sapien valve performs equally well for small and large aortic annuli, Edwards finds
The analysis adds to a debate about the effectiveness of Edwards versus Medtronic TAVR devices in patients with small aortic annuli, a fibrous ring around the heart’s valve.
By Nick Paul Taylor • June 6, 2024 -
Courtesy of Medtronic
Medtronic touts demand for PFA, adding to hype for the new ablation tech
CEO Geoff Martha told investors there has already been “strong adoption” of PFA devices and the category will be a big part of Medtronic's revenue growth in fiscal year 2025.
By Ricky Zipp • May 23, 2024 -
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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