Abbott snags early CE mark for Volt PFA device

With PFA becoming physicians’ preferred ablation method for treating AFib, Abbott is pushing to catch up with rival systems already on the market.

By Susan Kelly • March 28, 2025

Abbott gets FDA nod to begin IVL trial after rivals buy up competition

J&J acquired the IVL device maker Shockwave Medical last year for $13.1 billion, and Boston Scientific agreed to buy Bolt Medical in January for up to $664 million.

By Nick Paul Taylor • March 25, 2025

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Medical 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

Boston Scientific leads $175M investment in 4C Medical

The money will support an ongoing pivotal trial of 4C Medical Technologies' transcatheter mitral valve replacement device in the U.S. and Europe.

By Nick Paul Taylor • March 6, 2025

Steven Mickelsen, Farapulse founder, eyes next frontier in pulsed field ablation

Mickelsen, whose work led to the development of Boston Scientific’s fast-growing Farapulse device, is building a new PFA tool for ventricular tachycardia as CEO of startup Field Medical.

By Susan Kelly • March 4, 2025

FDA recall notice details J&J pause of Varipulse

Four of the 132 patients treated with Varipulse in the first two months of the U.S. launch had a form of stroke shortly after surgery.

By Nick Paul Taylor • March 3, 2025

Medtronic partners with Brainomix on AI stroke tool

Medtronic also recently teamed with Tempus to assess the use of artificial intelligence to identify people eligible for interventions like TAVR.

By Nick Paul Taylor • Feb. 28, 2025

VitalConnect raises $100M for heart monitor patch

VitalConnect will use the money to commercialize the monitor, which detects arrhythmias and competes with patches from companies including iRhythm.

By Nick Paul Taylor • Feb. 21, 2025

J&J resumes PFA cases, but analysts warn safety may hamper rollout

J.P. Morgan analysts said the findings of J&J’s investigation “could significantly hinder the product’s rollout in the U.S. and globally” and lead doctors to “de-prioritize Varipulse.”

By Nick Paul Taylor • Feb. 18, 2025

Edwards predicts second-half lift from TAVR label expansion

Executives expect a new label indication and a hoped-for easing of hospital capacity constraints to accelerate sales this year.

By Susan Kelly • Feb. 12, 2025

FDA posts early alert about BD device linked to 30 injuries, 4 deaths

The alert was posted one day after BD sent customers a letter warning about the risk of atherectomy catheters breaking.

By Nick Paul Taylor • Feb. 10, 2025

Pulse Biosciences names new CFO, continuing string of C-suite changes

Pulse, which named a new CEO last month, is pitching its pulsed field ablation technology as a way to shorten procedure times.

By Nick Paul Taylor • Feb. 5, 2025

Boston Scientific closes its year of PFA on a high note

Farapulse, Boston Scientific’s pulsed field ablation product, fueled year-over-year growth of nearly 171% in the fourth quarter for the company’s electrophysiology group.

By Ricky Zipp • Feb. 5, 2025

Top medtech trends in 2025: New products and M&A are bright spots, but Trump brings uncertainty

Experts highlighted surgical robotics, artificial intelligence and M&A as top trends this year. However, the Trump administration could create challenges for the industry.

By Ricky Zipp • Jan. 31, 2025

Getinge exits surgical perfusion, creating opportunity for Livanova

Getinge CEO Mattias Perjos said surgical perfusion has “been a struggling category” since an FDA consent decree forced the company off the U.S. market in 2015.

By Nick Paul Taylor • Jan. 30, 2025

Neko Health raises $260M to expand body scan service, fund R&D

The company uses various medical devices to noninvasively check moles, the heart and more.

By Nick Paul Taylor • Jan. 28, 2025

Doctors expect Boston Scientific to lead PFA race, survey finds

Physicians also expect greater use of Johnson & Johnson’s Varipulse system over the next two years despite the company’s current pause of U.S. cases, according to a poll by BTIG.

By Susan Kelly • Jan. 27, 2025

Abbott expects to launch first PFA device outside of the US this year

CEO Robert Ford also plans to expand sales of the company’s Lingo over-the-counter glucose sensors after a limited rollout.

By Elise Reuter • Jan. 22, 2025

J&J coordinating with FDA on US pause of Varipulse due to safety risks

Johnson & Johnson executives, on a Wednesday earnings call, did not provide a timeline for when U.S. Varipulse cases will restart after halting procedures in early January.

By Ricky Zipp • Jan. 22, 2025

Boston Scientific study meets goals for PFA in persistent AFib

The results will support the company’s application for expanded labeling of its popular Farapulse pulsed field ablation system in a larger group of patients with atrial fibrillation.

By Susan Kelly • Jan. 21, 2025

JPM25 recap: Robotics, PFA and OTC glucose sensors in the spotlight

CEOs from Medtronic, Intuitive Surgical, Boston Scientific and Dexcom were on hand this week in San Francisco to discuss the year ahead at the J.P. Morgan Healthcare Conference.

By Susan Kelly • Jan. 17, 2025

Boston Scientific ups PFA forecast, targets market leadership

At the J.P. Morgan Healthcare Conference, Boston Scientific forecast that pulsed field ablation will be used in more than 60% of atrial fibrillation procedures globally by 2026.

By Nick Paul Taylor • Jan. 15, 2025

Philips recall of heart monitor software tied to 109 injuries, 2 deaths

Some electrocardiogram events, such as atrial fibrillation or abnormally rapid heartbeats, over two years were not reviewed by healthcare professionals due to a data routing issue.

By Ricky Zipp • Jan. 14, 2025

CEO Geoff Martha tells JPM crowd Medtronic is ‘stacking growth drivers’

New technologies for atrial fibrillation, hypertension, diabetes and neurological conditions are poised for fast growth, Martha said Monday at the J.P. Morgan Healthcare Conference.

By Susan Kelly • Jan. 14, 2025

CMS starts Medicare coverage analysis for Medtronic, Recor renal denervation devices

J.P. Morgan analysts said the CMS’ review “validates the technology and could potentially move the needle on growth for Medtronic.”

By Nick Paul Taylor • Jan. 14, 2025

Eko Health names Justin Spencer as CFO

Spencer’s arrival at Eko comes months after the digital health company appointed his former colleague Brent Lang to its board of directors.

By Nick Paul Taylor • Jan. 10, 2025