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

Masimo picks Katie Szyman as CEO

Szyman led Edwards Lifesciences’ critical care unit for more than a decade before BD acquired the group last year. Her appointment “fits like a glove,” BTIG analyst Marie Thibault wrote.

By Susan Kelly • Jan. 22, 2025

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

AI in medtech is taking off. Here are 4 trends to watch in 2025.

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.

By Elise Reuter • 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

Medtronic names Thierry Piéton as CFO

Piéton fills an opening left by Karen Parkhill, who became HP’s CFO in August after eight years with Medtronic.

By Elise Reuter • 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

BD expands syringe, needle production capacity in Nebraska and Connecticut

BD invested $10 million last year to increase manufacturing capacity. The recent expansion has created more than 200 jobs.

By Ricky Zipp • Jan. 17, 2025

Tarver warns that US device supply chain vulnerabilities could harm patients

The new director of the FDA’s device center contrasted a European rule with the lack of mandatory reporting requirements for potential device shortages in the U.S.

By Nick Paul Taylor • Jan. 17, 2025

Hologic receives FDA warning letter over Biozorb implantable markers

Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.

By Elise Reuter • Updated Jan. 16, 2025

Intuitive CEO drills down on da Vinci 5 rollout, force feedback debate

Gary Guthart gave a glimpse of surgeons’ initial response to the new robot at the J.P. Morgan Healthcare Conference.

By Susan Kelly • Jan. 16, 2025

EU mulls retaliation after showing China’s bias against foreign device firms

A report found China limits EU-based device manufacturers’ access to its market through policies that favor local suppliers in an “unfair and discriminatory way.”

By Nick Paul Taylor • Jan. 16, 2025

Dexcom CEO talks Stelo sensor launch, OTC strategy

Kevin Sayer said at the J.P. Morgan Healthcare Conference that Dexcom also expects to release a 15-day glucose sensor in the second half of the year.

By Elise Reuter • Jan. 15, 2025

CMR Surgical makes interim CEO permanent

Massimiliano Colella joined the robot maker as chief commercial officer in 2023 and stepped into the top job when former CEO Supratim Bose resigned late last year.

By Susan Kelly • Jan. 15, 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

Medtronic inks distribution deal with Contego with option to buy firm

Medtronic will be the exclusive U.S. distributor of Contego Medical’s portfolio, which includes a carotid stent system and thrombectomy devices.

By Ricky Zipp • Jan. 13, 2025

EU medtech regulations reducing options for patients, companies say

Stakeholders branded the MDR and IVDR rules “unreasonably complicated,” “terrible for EU patients and doctors” and “a mess.”

By Nick Paul Taylor • Jan. 13, 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

Fire1 raises $120M to trial heart failure management system

Medtronic and Novo Holdings were among the investors in the funding round.

By Nick Paul Taylor • Jan. 10, 2025

Medtronic inks exclusive deal to sell Kuros bone graft device

In the five-year agreement, Medtronic will be the exclusive sales agent for Kuros' product in certain U.S. spine geographies.

By Nick Paul Taylor • Jan. 9, 2025

5 medtech trends to watch in 2025

After a busy 2024, experts called out competition in soft tissue robotics, uncertainty from a Trump White House and continued success for pulsed field ablation as trends to watch this year.

By Ricky Zipp • Jan. 9, 2025

J&J pauses Varipulse PFA cases in US

The temporary halt to investigate reported neurovascular events comes two months after Johnson & Johnson won FDA approval for the pulsed field ablation system.

By Susan Kelly • Jan. 8, 2025

Beta Bionics, maker of ‘bionic pancreas,’ files for IPO

Beta Bionics did not disclose the number of shares it will offer or a price range.

By Elise Reuter • Jan. 8, 2025