Medical Devices: Page 2
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Courtesy of CMR Surgical
CMR Surgical names new CFO
Shlomi Cohen takes over the role as the surgical robotics company focuses on global expansion and competing with market leader Intuitive Surgical.
By Susan Kelly • May 7, 2024 -
Courtesy of Masimo
Masimo’s at-home baby monitor cleared for use without prescription
A proposed separation of Masimo’s consumer business, which is currently under consideration, would likely include the Stork monitoring system.
By Susan Kelly • May 7, 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 Medtronic
Medtronic wins approval to sell renal denervation device in China
Medtronic expects sales in China of the Symplicity Spyral blood pressure treatment to “be modest in the short-term.”
By Nick Paul Taylor • May 7, 2024 -
Permission granted by Nextbeam
Deep DiveEtO causes cancer. Device sterilizers are scrambling to find alternatives.
No one solution can match the scope and scale of ethylene oxide, but a “multi-pronged approach” can help reduce emissions, an FDA official said.
By Elise Reuter • May 6, 2024 -
Ramberg via Getty Images
UK sets out position on regulating AI as a medical device
Some AI products that currently can be put on the market without conformity assessment will move to a higher risk class, requiring more scrutiny.
By Nick Paul Taylor • May 3, 2024 -
Courtesy of Cue Health Press Kit
Cue Health to cut 230 employees
Declining COVID-19 test sales have forced Cue to eliminate hundreds of jobs in multiple rounds of layoffs over the past several years.
By Elise Reuter • May 3, 2024 -
Retrieved from Food and Drug Administration.
Cardinal receives FDA warning letter over unapproved syringes
The agency has recently increased scrutiny of plastic syringes made in China because of safety concerns, including blocking imports from two Chinese manufacturers.
By Elise Reuter • May 2, 2024 -
N/A via Getty Images
Philips reaches major settlements related to respiratory devices recall
A judge recently finalized an economic claims settlement, and Philips said it reached an agreement on medical claims.
By Elise Reuter • May 2, 2024 -
Nastassia Samal via Getty Images
Medline to buy Ecolab’s surgical products for nearly $1B
The medical products supplier will acquire Ecolab’s sterile drapes and fluid temperature management systems.
By Susan Kelly • May 1, 2024 -
Permission granted by Senseonics
Senseonics gets FDA clearance to pair CGM implant with insulin pumps
Analysts said the designation and planned one-year sensor could help Senseonics’ device appeal to more patients.
By Nick Paul Taylor • May 1, 2024 -
Courtesy of Endomagnetics
Hologic to buy Endomagnetics for $310M
Endomagnetics, which makes guidance technology for breast cancer surgery, brought in about $35 million in revenue last year.
By Elise Reuter • April 30, 2024 -
Courtesy of Abbott Laboratories
Abbott wins FDA approval for Esprit resorbable scaffold
While RBC analysts wrote there’s “strong appetite” for the system, BTIG said the need to train centers could result in a gradual launch.
By Nick Paul Taylor • April 30, 2024 -
mathisworks via Getty Images
Medtronic to lay off 44 employees in California
Medtronic’s latest layoff plan adds to what has become a long list of job cuts for the medical device industry this year.
By Ricky Zipp • April 29, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips agrees to $1.1B settlement of US respiratory recall lawsuits
CEO Roy Jakobs said on a first-quarter earnings call that “for the U.S., this is as final as it can get.”
By Nick Paul Taylor • April 29, 2024 -
Courtesy of Medtronic
Medtronic wins FDA approval for Inceptiv closed-loop spinal cord stimulator
Evercore analysts said the launch could help Medtronic regain market share in the coming quarters.
By Nick Paul Taylor • April 29, 2024 -
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 -
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
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