The Latest
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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.
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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.
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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.
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Labcorp gains FDA approval for companion diagnostic to Pfizer gene therapy
The test would determine if patients are eligible for Pfizer’s new hemophilia B treatment by detecting if they have been exposed to a virus that could make the gene therapy less effective.
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FDA defends LDT final rule, while critics fear it upends lab industry
The new policy aims to ensure important diagnostics remain available to patients, but some experts caution the increased regulatory burdens could slow access to testing.
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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.
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Hologic to buy Endomagnetics for $310M
Endomagnetics, which makes guidance technology for breast cancer surgery, brought in about $35 million in revenue last year.
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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.
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FDA finalizes lab developed test rule despite industry opposition
Risks associated with the tests have increased, requiring greater oversight to protect patients, the agency contends.
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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.”
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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.
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Livanova says patient data obtained in 2023 cyberattack
Livanova learned that an unauthorized party obtained patient data, including Social Security numbers and health conditions, during last year’s attack.
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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.
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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.
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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.
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Labcorp to acquire Invitae’s assets for $239M
William Blair analyst Andrew Brackmann said Labcorp is being aggressive in its M&A strategy, after announcing last month it would buy several of Bioreference Health’s testing businesses.
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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.
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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.
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Freenome to cut more than 100 employees in restructuring
Intended to preserve resources, the layoffs come weeks after Freenome released study data on its blood test for colorectal cancer that fell short of competitors’ results.
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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.
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Medtech’s top executive moves in 2024
Philips, Illumina, Insulet and Exact Sciences have all gained new CFOs in recent weeks.
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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.
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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.
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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.
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FTC votes to ban noncompetes, with far-reaching effects on doctors
The FTC estimates the final rule would lower healthcare costs by $194 billion over the next decade, while freeing up physicians to more easily move between employers.