Medical Devices: Page 2
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Courtesy of Stryker
4 takeaways from AAOS 2025
Stryker unveiled its updated Mako surgical robot and orthopedic companies expect procedure volumes to remain steady despite recession fears.
By Elise Reuter • March 17, 2025 -
Sarah Silbiger via Getty Images
FDA adds hemodialysis devices to shortage list amid B. Braun disruption
The disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and could continue through the early fall of 2025.
By Nick Paul Taylor • March 17, 2025 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical 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 -
Anna Moneymaker/Getty Images via Getty Images
Dr. Oz stresses need for faster Medicare coverage of new devices during confirmation hearing
Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical devices once they’re FDA-approved.
By Ricky Zipp • March 14, 2025 -
Permission granted by Vicarious Surgical
Vicarious Surgical appoints Sarah Romano as CFO
Romano will arrive at the robotics company just as Chief Operating Officer John Mazzola is set to retire on April 1.
By Nick Paul Taylor • March 14, 2025 -
Kevin Dietsch via Getty Images
EPA to reconsider emissions standards for medical device sterilizers
Last year, the EPA issued a final rule that would limit emissions of ethylene oxide, a cancer-causing gas used to sterilize medical devices.
By Elise Reuter • March 13, 2025 -
Retrieved from Screenshot: Johnson & Johnson on March 13, 2025
J&J’s Monarch robot wins FDA nod for AI software update
Using Nvidia and GE Healthcare technology, the robotic surgery system is intended to help doctors detect lung cancer earlier.
By Susan Kelly • March 13, 2025 -
koto_feja via Getty Images
Vivani to spin off neurostimulation business
The independent company will trade as Cortigent and advance brain implants to help people recover body functions such as vision and movement.
By Nick Paul Taylor • March 13, 2025 -
Sarah Silbiger via Getty Images
FDA accuses Mid-Link of copying or falsifying medical device test data
The agency will reject all data from the Chinese service provider’s studies after Mid-Link failed to address concerns outlined in a warning letter last year, FDA officials said.
By Nick Paul Taylor • March 12, 2025 -
Permission granted by Capstan Medical
Capstan brings surgical robot to valve replacement
Capstan Medical, a startup focused on robotic-assisted mitral and tricuspid valve replacement, recently completed its first patient implants.
By Susan Kelly • March 11, 2025 -
Don Wu via Getty Images
ECRI warns insufficient AI governance threatens patient safety
ECRI included other medtech-related threats on its list of patient safety concerns, noting that cybersecurity breaches can delay care and diagnostic errors can lead to improper treatment.
By Nick Paul Taylor • March 11, 2025 -
Courtesy of Orthofix
Orthofix’s fired execs’ lewd, ‘graphic’ texts surface in legal battle
Orthofix didn’t originally specify the reasons behind the 2023 firing of its CEO, CFO and CLO. Now, a court case is illuminating the story behind the terminations.
By Maura Webber Sadovi • March 10, 2025 -
FG Trade via Getty Images
New FDA pulse oximetry guidelines could stall under Trump
The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts raised concerns that it might not be finalized.
By Elise Reuter • March 10, 2025 -
Courtesy of Business Wire
Dexcom receives warning letter based on FDA inspections of 2 plants
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek clearance for new products.
By Nick Paul Taylor • March 10, 2025 -
Stock via Getty Images
FTC challenges $627M private equity takeover of Surmodics
The regulator said the buyout “would lead to a highly concentrated market for outsourced hydrophilic coatings and eliminate significant head-to-head competition.”
By Nick Paul Taylor • March 7, 2025 -
Mario Tama via Getty Images
Trump tariffsIllumina’s DNA sequencers hit with China import ban
Illumina is not banned from operating in the country and will continue to serve its existing customers, a company spokesperson said.
By Susan Kelly • March 6, 2025 -
Courtesy of Boston Scientific
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 -
Patrik Stollarz / Staff via Getty Images
Philips pulls endovascular implant from market after 20 injuries
Philips stopped selling its Tack endovascular system because of cases where additional interventions were needed to remove the implant.
By Elise Reuter • March 5, 2025 -
Andrew Harnik via Getty Images
Trump’s trade war heats up as countries retaliate against tariffs
Mexico, Canada and China all announced they would counter the president's orders after additional duties went into effect this week.
By Philip Neuffer , Edwin Lopez , Max Garland • March 4, 2025 -
Permission granted by Staar Surgical
Staar Surgical names Stephen Farrell as CEO
Farrell replaces Tom Frinzi on the heels of a challenging year for the eye implant maker marked by a demand slowdown in China, its largest market.
By Susan Kelly • March 4, 2025 -
Andrew Harnik via Getty Images
Medical device firms brace for effect of White House tariffs
President Donald Trump upped tariffs on China and said delayed tariffs on Mexico and Canada would take effect. Catch up on MedTech Dive’s latest coverage.
By Elise Reuter • March 4, 2025 -
Andrew Harnik via Getty Images
Trump hikes tariffs on China by 10%
The president also maintained that the pause on duties for Canada and Mexico will come to an end Tuesday.
By Philip Neuffer • Updated March 3, 2025 -
Stock via Getty Images
Olympus recalls lung biopsy devices linked to 26 serious injuries
The FDA, which published a Class I recall notice, said the tip of the guide sheath has detached from some devices and fallen off in the patient.
By Nick Paul Taylor • March 4, 2025 -
Courtesy of Johnson & Johnson
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 -
Courtesy of Brainomix
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 -
Courtesy of Illumina
Illumina to lay off 96 San Diego employees
The latest job cuts at Illumina’s California headquarters are not part of a broad-based reduction, a company spokesperson said.
By Susan Kelly • Feb. 28, 2025
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