Medical Devices
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Courtesy of Fresenius Medical Care
Fresenius Medical Care recalls 2M dialysis devices over toxin exposure risk
Nearly 2.2 million devices are affected by the recall. Fresenius Medical Care will not have to remove products due to the issue.
By Nick Paul Taylor • April 26, 2024 -
Courtesy of Edwards Lifesciences
Edwards gets Q1 boost as Pascal valve repair sales ramp up
New mitral and tricuspid valve treatments are attracting strong demand, but analysts said transcatheter aortic valve replacement sales were shy of expectations.
By Susan Kelly • April 26, 2024 -
Trendline
The EU Medical Device Regulation
While the European Union’s MDR went into effect in May 2021, device makers still face a range of uncertainties and potential problems with continued extensions and outstanding questions still in play.
By MedTech Dive staff -
Courtesy of U.S. Food and Drug Administration
Infutronix infusion pump recall linked to 6 injuries, 1 death
The FDA’s recall notice sheds light on the impact to patients weeks after the company told customers it would pull Nimbus pumps from the market.
By Nick Paul Taylor • April 26, 2024 -
Courtesy of Philips
Judge approves settlement of more than $500M from Philips recall
Philips could be on the hook for more costs if eligible claims for recalled or returned respiratory devices exceed the amount agreed to in the settlement.
By Elise Reuter • April 25, 2024 -
Courtesy of Exo
Exo adds FDA-cleared AI tools to handheld ultrasound system
Exo sees the new capabilities as especially helpful for healthcare providers in rural and under-resourced settings.
By Nick Paul Taylor • April 25, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips failed to report corrections of CT machines, FDA says in warning letter
After a 2023 inspection, the FDA found three unreported field corrections related to CT machines and 19 other recalls of radiology devices.
By Elise Reuter • April 25, 2024 -
AnkiHoglund via Getty Images
Medtech’s top executive moves in 2024
Philips, Illumina, Insulet and Exact Sciences have all gained new CFOs in recent weeks.
By Susan Kelly • April 25, 2024 -
Sean Gallup via Getty Images
EU launches probe of China’s medical device market
China’s procurement market for medical devices has gradually become more closed for European and foreign companies, the European Commission alleges.
By Susan Kelly • April 24, 2024 -
Permission granted by Medtronic
Medtronic names Yarmela Pavlovic as chief regulatory officer
Pavlovic, who was a partner at the law firm Manatt, Phelps & Phillips before joining Medtronic, will gain a new title, but her role will stay the same.
By Nick Paul Taylor • April 24, 2024 -
Courtesy of Boston Scientific
Boston Scientific gives first look at Farapulse US rollout
CEO Mike Mahoney would not provide specific sales numbers for the device, but hyped the pulsed field ablation system as the “most transformational product” he’s seen in his time with the company.
By Ricky Zipp • April 24, 2024 -
Courtesy of Elekta
GE Healthcare subsidiary expands radiation therapy partnership with Elekta
MIM Software, which GE Healthcare acquired earlier this month, will work with Elekta to improve treatment planning and workflows.
By Elise Reuter • April 23, 2024 -
Courtesy of Intuitive Surgical
Intuitive’s da Vinci 5 robot could widen ‘already substantial’ lead: analysts
Truist Securities analysts wrote that Medtronic and Johnson & Johnson could “be relegated to niche players” in surgical robotics.
By Nick Paul Taylor • April 23, 2024 -
Courtesy of Boston Scientific
Boston Scientific, Dexcom and Edwards next as earnings season rolls on
J.P. Morgan analysts expect this week’s results to be “very good” following reports from J&J, Abbott and Intuitive Surgical.
By Nick Paul Taylor • April 23, 2024 -
Stock via Getty Images
FDA approves Lumicell’s breast cancer imaging tool
Lumicell developed the technology to enable physicians to detect residual cancer in the breast cavity after surgery.
By Nick Paul Taylor • April 22, 2024 -
Sarah Silbiger via Getty Images
Exactech recalls shoulder devices after initially declining to act
After the FDA issued a public safety notice and sent Exactech a warning letter, the firm agreed to recall shoulder implants due to packaging issues.
By Nick Paul Taylor • April 22, 2024 -
Courtesy of Intuitive Surgical
Intuitive’s rollout of new da Vinci 5 robot steals Q1 spotlight
While Intuitive has already placed eight new surgical robots, executives cautioned system placements could be choppy in the coming months.
By Susan Kelly • April 19, 2024 -
Sascha Schuermann via Getty Images
Spinoffs, sales and tuck-ins top medtech deal priorities: Moody’s
After J&J’s $13.1 billion purchase of Shockwave Medical, Moody’s analysts see the potential for other larger pick-ups “if interest rates substantially decrease.”
By Nick Paul Taylor • April 19, 2024 -
Permission granted by Scopio Labs
Scopio Labs wins de novo nod for bone marrow analysis software
Scopio can now add the application to its imaging platforms that allow users to view blood samples digitally rather than under a microscope.
By Nick Paul Taylor • April 18, 2024 -
Brad Barket via Getty Images
23andMe CEO plans to take company private
Anne Wojcicki wants to buy all outstanding shares of the DNA testing firm, which has seen its stock slump in recent years.
By Elise Reuter • April 18, 2024 -
Courtesy of Boston Scientific
Boston Scientific recalls blood-blocking agent linked to 2 deaths
Seven injuries and 11 incidents were also associated with the safety issue.
By Nick Paul Taylor • April 18, 2024 -
Patrik Stollarz / Staff via Getty Images
‘An incredible undertaking’: 5 takeaways from Philips consent decree
Under the agreement, the FDA will use rare powers to require repairs, replacements or refunds for recalled respiratory machines.
By Elise Reuter • Updated April 17, 2024 -
Courtesy of Abbott Laboratories
Abbott looks to ‘highly productive’ device pipeline for future growth
CEO Robert Ford highlighted new and upcoming products throughout the earnings call, calling the recently approved Triclip valve a “billion-dollar opportunity."
By Elise Reuter • April 17, 2024 -
Sarah Silbiger via Getty Images
FDA warns Soulaire to stop selling device outside authorized uses
Soulaire marketed its external counterpulsation system to grow new arteries, repair organ dysfunction and treat COVID-19, among other uses, without evidence.
By Nick Paul Taylor • April 17, 2024 -
Permission granted by GE HealthCare
GE Healthcare imaging CEO to resign
Jan Makela plans to leave the company in July to join another firm.
By Elise Reuter • April 16, 2024 -
Courtesy of Johnson & Johnson
‘We think in decades’: J&J’s $30B spending spree may not be over
After Johnson & Johnson has doled out more than $30 billion for Abiomed, Laminar and Shockwave Medical, are more medtech deals on the way?
By Ricky Zipp • April 16, 2024
