Cardiac
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Medtronic wins FDA approval for defibrillation lead
Omniasecure, which was authorized for placement in the heart’s right ventricle, is the world’s smallest defibrillation lead, according to Medtronic.
By Nick Paul Taylor • April 30, 2025 -
News roundup
4 PFA studies in the spotlight at Heart Rhythm 2025
Boston Scientific, Medtronic, Abbott and J&J unveiled new data for their PFA devices in tandem with the Heart Rhythm Society’s annual meeting.
By Susan Kelly • April 29, 2025 -
Earnings & Tariffs
Edwards shrugs off tariffs, backs 2025 profit forecast
The heart valve specialist saw better-than-expected TAVR sales in the first quarter as hospitals addressed capacity constraints that have dogged its core business.
By Susan Kelly • Updated 5 hours ago -
Field Medical raises $40M for PFA in ventricular tachycardia
Led by Farapulse founder Steven Mickelsen, Field has developed a pulsed field ablation device to tackle the dangerous heart rhythm disorder.
By Susan Kelly • April 23, 2025 -
Earnings & Tariffs
Boston Scientific is ‘very bullish’ on 2025 despite $200M tariff hit
The company joins Johnson & Johnson and Abbott as top medtech firms that expect an impact in the hundreds of millions of dollars from President Donald Trump’s tariff policies.
By Ricky Zipp • April 23, 2025 -
Intuitive, Boston Scientific and Edwards next up in medtech earnings
Tariff talk will continue in the second week of earnings season, but the updates could also shed light on trends and competitive dynamics in key markets.
By Nick Paul Taylor • April 21, 2025 -
Illumina, Tempus AI partner to drive genomic testing beyond cancer
The partners plan to build evidence packages that standardize comprehensive genomic profiling and other molecular testing across all major diseases.
By Nick Paul Taylor • April 18, 2025 -
J&J’s electrophysiology sales dip amid slow Varipulse start
Johnson & Johnson’s electrophysiology unit struggled in the first quarter, as the company chases Medtronic and Boston Scientific in the red-hot pulsed field ablation market.
By Ricky Zipp • April 16, 2025 -
Edwards receives CE mark for Sapien M3 mitral valve replacement device
The replacement system is launching into markets already served by repair devices, namely Edwards’ Pascal and Abbott’s Mitraclip.
By Nick Paul Taylor • April 15, 2025 -
News roundup
Microbot posts pivotal surgical robot data; GE Healthcare hires Patient Care Solutions leader
Microbot reported positive data on its single-use endovascular robot. Elsewhere, GE Healthcare named a new business leader, and Puzzle Medical Devices raised $31 million.
By Nick Paul Taylor • April 10, 2025 -
J&J starts IVL trial in ‘difficult-to-cross’ coronary arteries
The device is differentiated from other Shockwave products, and rival catheters from Abbott and Boston Scientific, because it emits waves from its tip.
By Nick Paul Taylor • April 8, 2025 -
Boston Scientific’s Farapulse matches Medtronic cryoablation in trial
Atrial tachyarrhythmia recurred in 39 patients treated with Boston Scientific’s Farapulse PFA device, while 53 people had recurrence in the Medtronic cryoablation group.
By Nick Paul Taylor • April 3, 2025 -
3 takeaways from ACC 2025
Medtronic, Abbott and Boston Scientific had updates on their devices used in heart valve disease treatment at the event.
By Susan Kelly • April 2, 2025 -
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 -
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 -
Q&A
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