The Latest

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  EU mulls retaliation after showing China’s bias against foreign device firms

  A report found China limits EU-based device manufacturers’ access to its market through policies that favor local suppliers in an “unfair and discriminatory way.”

  Medical Devices

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  Dexcom CEO talks Stelo sensor launch, OTC strategy

  Kevin Sayer said at the J.P. Morgan Healthcare Conference that Dexcom also expects to release a 15-day glucose sensor in the second half of the year.

  Medical Devices

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  Boston Scientific ups PFA forecast, targets market leadership

  At the J.P. Morgan Healthcare Conference, Boston Scientific forecast that pulsed field ablation will be used in more than 60% of atrial fibrillation procedures globally by 2026.

  Medical Devices

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  CMR Surgical makes interim CEO permanent

  Massimiliano Colella joined the robot maker as chief commercial officer in 2023 and stepped into the top job when former CEO Supratim Bose resigned late last year.

  Medical Devices

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  Philips recall of heart monitor software tied to 109 injuries, 2 deaths

  Some electrocardiogram events, such as atrial fibrillation or abnormally rapid heartbeats, over two years were not reviewed by healthcare professionals due to a data routing issue.

  Medical Devices

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  CEO Geoff Martha tells JPM crowd Medtronic is ‘stacking growth drivers’

  New technologies for atrial fibrillation, hypertension, diabetes and neurological conditions are poised for fast growth, Martha said Monday at the J.P. Morgan Healthcare Conference.

  Medical Devices

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  CMS starts Medicare coverage analysis for Medtronic, Recor renal denervation devices

  J.P. Morgan analysts said the CMS’ review “validates the technology and could potentially move the needle on growth for Medtronic.”

  Medical Devices

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  Medtronic inks distribution deal with Contego with option to buy firm

  Medtronic will be the exclusive U.S. distributor of Contego Medical’s portfolio, which includes a carotid stent system and thrombectomy devices.

  Medical Devices

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  Illumina, Nvidia team to use AI in foundation models

  Nvidia’s partnership with the gene sequencing company is one of several healthcare collaborations revealed Monday by the computing giant.

  Diagnostics

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  EU medtech regulations reducing options for patients, companies say

  Stakeholders branded the MDR and IVDR rules “unreasonably complicated,” “terrible for EU patients and doctors” and “a mess.”

  Medical Devices

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  Deep Dive // 2025 outlook

  5 medtech trends to watch in 2025

  After a busy 2024, experts called out competition in soft tissue robotics, uncertainty from a Trump White House and continued success for pulsed field ablation as trends to watch this year.

  Medical Devices

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  More hospitals need to assess predictive models for accuracy, bias: Health Affairs

  Just 61% of hospitals surveyed evaluated models for accuracy on their own data, and less than half evaluated the models for bias.

  AI

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  Eko Health names Justin Spencer as CFO

  Spencer’s arrival at Eko comes months after the digital health company appointed his former colleague Brent Lang to its board of directors.

  Digital Health

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  Fire1 raises $120M to trial heart failure management system

  Medtronic and Novo Holdings were among the investors in the funding round.

  Medical Devices

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  J&J pauses Varipulse PFA cases in US

  The temporary halt to investigate reported neurovascular events comes two months after Johnson & Johnson won FDA approval for the pulsed field ablation system.

  Medical Devices

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  Medtronic inks exclusive deal to sell Kuros bone graft device

  In the five-year agreement, Medtronic will be the exclusive sales agent for Kuros' product in certain U.S. spine geographies.

  Medical Devices

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  Boston Scientific to buy remaining Bolt Medical stake for up to $664M

  The deal for Bolt, developer of an intravascular lithotripsy system to treat coronary and peripheral artery disease, continues Boston Scientific’s brisk run of acquisitions.

  Medical Devices

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  Beta Bionics, maker of ‘bionic pancreas,’ files for IPO

  Beta Bionics did not disclose the number of shares it will offer or a price range.

  Medical Devices

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  FDA finalizes guidance on device shortage reporting rules

  The final version adds information on the devices affected by the guidance and the impact of revised legislation on voluntary notifications.

  Medical Devices

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  Stryker to buy Inari Medical for nearly $5B

  Stryker made several small deals last year but lacked a larger acquisition like its nearly $5 billion proposal for Inari Medical.

  M&A

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  FDA aims to stem AI device bias, boost transparency in draft guidance

  The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI devices.

  Medical Devices

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  Outset Medical to pay down debt after raising nearly $300M

  Stifel analyst Rick Wise said the financing, a combination of private stock placement and new loans, should help the dialysis device maker return to revenue growth.

  Medical Devices

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  FDA issues much-anticipated guidance on pulse oximeters

  The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin pigmentation.

  FDA

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  FDA posts early alert about safety risk of Medline’s fluid delivery sets

  The agency issued the alert as part of a pilot to improve the timeliness of communications about actions it believes are likely to be high-risk recalls. 

  Medical Devices