Cardiac
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magicmine via Getty Images
Recalled heart devices had limited clinical testing, study finds
Just 30 of 157 heart devices with Class I recalls underwent premarket clinical testing, according to a study published in the Annals of Internal Medicine.
By Elise Reuter • Sept. 24, 2024 -
Courtesy of Cook Medical
Merit Medical inks $210M takeover of Cook’s lead management business
Merit predicts the portfolio, which includes devices used in procedures to remove or replace heart rhythm device leads, will add $40 million a year to its sales.
By Nick Paul Taylor • Sept. 18, 2024 -
Courtesy of Spectrawave
J&J leads $50M financing for imaging company Spectrawave
The Series B round will support commercial expansion and product additions for Spectrawave’s system used in the treatment of coronary artery disease.
By Susan Kelly • Sept. 11, 2024 -
SDI Productions via Getty Images
European heart group recommends renal denervation for some patients
The European Society of Cardiology said the treatment may be considered for certain patients with uncontrolled, drug-resistant high blood pressure but outlined lingering concerns.
By Nick Paul Taylor • Sept. 4, 2024 -
Permission granted by Johnson & Johnson
J&J to buy heart failure implant maker V-Wave for up to $1.7B
J&J has agreed to pay $600 million upfront for the private company as it works to expand its portfolio of cardiovascular devices.
By Susan Kelly • Aug. 20, 2024 -
Courtesy of Edwards Lifesciences
Edwards spends $1.2B on 2 heart device firms, extending deal streak
Alongside the acquisitions, Edwards reported a slowdown in its core TAVR business in the second quarter that sent its shares tumbling.
By Susan Kelly • July 25, 2024 -
Courtesy of Boston Scientific
Boston Scientific tips strong growth for Farapulse after successful launch
Questions on Boston Scientific’s pulsed field ablation system once again dominated the company’s earnings call.
By Ricky Zipp • July 24, 2024 -
Permission granted by Medtronic
Q&A‘Our next frontier is prediction’: Medtronic on AI and heart disease
Stacey Churchwell, who leads the company’s cardiovascular diagnostics and services business, says artificial intelligence is reducing false positives in its insertable cardiac monitors, saving clinicians valuable time.
By Susan Kelly • July 22, 2024 -
Permission granted by Abbott
Abbott previews PFA, over-the-counter CGM markets
Electrophysiology sales held up against rivals’ launches of pulsed field ablation systems. Meanwhile, Abbott is gauging sales of its first OTC CGMs.
By Elise Reuter • July 18, 2024 -
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 -
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
