The Latest

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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.

  Policy & Regulation

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Policy & Regulation

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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.”

  Medical Devices

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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.

  Medical Devices

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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.

  Cybersecurity

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  M&A

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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.

  Legal

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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.

  Medical 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. 

  Diagnostics

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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.

  Digital Health

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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.

  Medical Devices

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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.

  Legal

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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.

  Medical Devices

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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.

  Medical Devices

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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.

  Legal

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  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.

  Medical Devices

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  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.

  Medical Devices

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  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.

  Medical Devices

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  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.

  Medical Devices

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