The Latest

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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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  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.

  M&A

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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.

  Medical Devices

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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.

  Medical Devices

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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.”

  Medical Devices

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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.

  Medical Devices

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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.

  M&A

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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.

  Medical Devices

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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.

  Medical Devices

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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

  Medical Devices

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  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."

  Medical Devices

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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.

  Clinical Trials

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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.”

  Diagnostics

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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.

  Medical Devices

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  ‘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?

  Medical Devices

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  Solventum appoints Shirley Edwards to board of directors

  The 3M spinoff highlighted Edwards’ expertise in mergers and acquisitions and corporate governance as an asset.

  Medical Devices

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  GE Healthcare imaging CEO to resign

  Jan Makela plans to leave the company in July to join another firm.

  Medical Devices

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  Edwards pushes back on Medtronic’s head-to-head TAVR trial

  Edwards Lifesciences and Wall Street analysts questioned the results of Medtronic’s women-focused study, claiming the data are inconsistent with real-world evidence.

  Clinical Trials

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