The Latest
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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.
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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.
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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.
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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.
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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.
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Cancer test maker Dermtech to cut 100 jobs, explore strategic options
Dermtech, which will not hold a first-quarter earnings call, said the layoffs are part of a broader effort to “significantly reduce” expenses.
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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.
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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.
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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.”
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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.
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Bruker to acquire Nanostring for $393M
Bruker made an offer roughly two months after Nanostring filed for bankruptcy protection and said it may restructure.
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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.
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Boston Scientific recalls blood-blocking agent linked to 2 deaths
Seven injuries and 11 incidents were also associated with the safety issue.
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‘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.
Updated April 17, 2024 -
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."
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Lilly obesity drug shows benefit in sleep disorder study, pointing to new use
Positive data for Lilly’s medicine tirzepatide in sleep apnea are the latest signal the benefits of GLP-1 agonists could extend beyond diabetes and weight loss.
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Files taken from Orasure systems in cybersecurity incident
Orasure believes it has contained the incident and “preserved the integrity of its core financial and operational systems.”
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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.