Medical Devices: Page 2
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Elekta appoints Jakob Just-Bomholt as CEO
The company cited Just-Bomholt’s strategic leadership, international experience and ability to drive profitable growth and global expansion as evidence he is the right person for the job.
By Nick Paul Taylor • June 10, 2025 -
Medtronic names Kate Benedict president of acute care and monitoring
Medtronic had planned to spin out the two units before consolidating them into one segment last year.
By Elise Reuter • June 10, 2025 -
Explore the Trendlineâž”
Sarah Silbiger via Getty ImagesTrendlineMedical 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 -
Baxter recalls Novum pump linked to 1 serious injury
The company has asked users to monitor patients frequently to ensure the appropriate infusion is being delivered.
By Nick Paul Taylor • Updated June 11, 2025 -
Judge rules J&J unit must pay $442M in antitrust case
A federal judge awarded triple damages after a jury found Biosense Webster withheld support to hospitals that bought reprocessed catheters.
By Elise Reuter • June 9, 2025 -
EU plan would limit Chinese device makers in Europe
The move comes after a recent investigation found Chinese government procurement practices discriminate against EU companies in China’s domestic market.
By Susan Kelly • June 6, 2025 -
Medtronic removes tracheostomy tubes due to dislodging risk
If the tube moves out of place, it could prevent a patient from breathing or block the airway. A Medtronic spokesperson said patient harm was reported in some cases.
By Elise Reuter • June 6, 2025 -
Owens & Minor spikes $1.36B Rotech buyout over regulatory barriers
The companies scrapped the merger because securing FTC clearance “proved unviable in terms of time, expense and opportunity.”
By Nick Paul Taylor • June 6, 2025 -
Outset Medical appoints Renee Gaeta as CFO
Gaeta’s last role was a brief stint at Shockwave, which named her CFO two months before accepting J&J’s $13.1 billion takeover offer.
By Nick Paul Taylor • June 5, 2025 -
Neuralink raises $650M to help expand patient access
Elon Musk’s brain implant startup said five people with severe paralysis are now using the device.
By Elise Reuter • June 4, 2025 -
Smiths Medical recalls infusion pumps over 3 problems
Smiths has not reported any serious injuries or deaths related to the issues, but the FDA sees a risk of harm.
By Nick Paul Taylor • June 4, 2025 -
J&J may take a softer tariff hit after US-China pause, CFO says
Joseph Wolk told an investor conference that the company’s tariff estimate is a “moving target” as trade talks continue with China and Europe and Section 232 investigations are ongoing.
By Susan Kelly • June 4, 2025 -
Clairity receives FDA OK for breast cancer risk prediction tool
The startup received de novo authorization for the AI tool, the first of its kind that analyzes mammogram images to predict breast cancer risk over five years.
By Elise Reuter • June 3, 2025 -
Q&A
Nvidia’s David Niewolny on the future of AI in medical devices
Nvidia, which is already working with J&J and Medtronic, plans to partner with medtech companies to build platforms for AI-enabled robotics, imaging and other features.
By Elise Reuter • June 2, 2025 -
Q&A
Beta Bionics CEO, CFO on how to take a company public
CEO Sean Saint and CFO Stephen Feider spoke about what’s different now that the company is public and the long journey of pursuing an IPO.
By Ricky Zipp • June 2, 2025 -
Bivacor wins FDA breakthrough nod for titanium total artificial heart
The company has so far treated patients who were weeks or months away from a transplant, but the device is theoretically suitable for longer-term use.
By Nick Paul Taylor • June 2, 2025 -
The medtech IPO window is finally open. Or is it?
After a three-year IPO drought, the industry is questioning whether the window for medtech public offerings is open following a small burst of activity.
By Ricky Zipp • Updated June 3, 2025 -
Boston Scientific plans changes to expected $200M tariff hit as situation shifts
The company also shared more details of its exit from the TAVR market and the impact of FDA layoffs on product review times.
By Nick Paul Taylor • May 29, 2025 -
Boston Scientific ends TAVR sales; J&J shares Monarch robot data
Boston Scientific said it would halt worldwide sales of its Acurate devices due to “increased clinical and regulatory requirements.”
By Elise Reuter • May 28, 2025 -
FDA finds Chinese lab copied or falsified data, endangering patients
The FDA said the findings raise doubts about the reliability and viability of premarket submissions based on the company’s data.
By Nick Paul Taylor • May 28, 2025 -
Abbott wins FDA approval for mitral valve replacement device, teeing up Edwards competition
Abbott said the Tendyne system addresses a significant unmet need in cardiac care, providing an option for patients ineligible for open heart surgery and whose valves cannot be successfully repaired with MitraClip.
By Susan Kelly • May 28, 2025 -
Zimmer hires former Nevro CEO Kevin Thornal
Thornal will join the orthopedics company as group president for global businesses and the Americas, a newly created position.
By Susan Kelly • May 27, 2025 -
Trump calls for 50% tariffs on EU
The duties are slated to take effect July 9 as the bloc and the U.S. reengage on trade talks, the president said.
By Philip Neuffer • Updated May 27, 2025 -
BD recalls esophagogastric tubes linked to 2 serious injuries, 1 death
A problem when preparing the devices for use can delay diagnosis or treatment, leading BD to update its instructions.
By Nick Paul Taylor • May 27, 2025 -
Stryker wins FDA clearance for minimally invasive back pain treatment
The company will compete with a device Boston Scientific acquired for $850 million.
By Nick Paul Taylor • May 22, 2025 -
Why Medtronic plans to spin out its diabetes business
While some analysts questioned why Medtronic would leave a fast-growing market, others backed the company’s plan to focus on segments with higher margins.
By Elise Reuter • May 22, 2025