The Latest

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  Abiomed heart pump recall labeled Class I by FDA, no deaths reported

  The recall, tied to specific sets of the Impella 5.5 with SmartAssist, comes just months after Johnson & Johnson paid $16.6 billion for Abiomed.

  Updated June 5, 2023

  Medical Devices

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  Grail blames vendor glitch for patient notifications of incorrect cancer diagnosis

  The erroneous letters from telemedicine provider PWNHealth come as Grail’s parent company, Illumina, is facing pressure from regulators and shareholders to divest the liquid biopsy maker.

  Diagnostics

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  Novo Nordisk says in talks to acquire French device-maker Biocorp for $165M

  The offer per share is about 20% more than Biocorp’s closing stock price on June 2. The two companies plan to focus on drug delivery solutions for chronic diseases, such as diabetes.

  Updated June 6, 2023

  Medical Devices

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  Masimo board accepts appointment of activist investor’s nominee, with caveats

  The agreement to let former J&J executive Michelle Brennan join its board comes as Masimo, and founder and CEO Joe Kiani, are working to fend off activist investor Quentin Koffey.

  Medical Devices

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  Cue Health’s inability to find post-COVID markets for testing prompts Goldman downgrade

  The analysts warned switching to non-COVID-19 tests will mean entering a competitive market “where larger companies with financial resources have an established installed base.”

  COVID-19

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  Medtronic names former Amazon robotics VP as technology chief

  Ken Washington, who has also served as chief technology officer at Ford and Lockheed Martin, will be charged with driving growth through innovation at the world’s largest medical device maker by revenue.

  Updated June 5, 2023

  Medical Devices

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  Deaths reported with Philips ventilators, sleep apnea machines still climbing

  The FDA reported 40 additional deaths tied to the recall of Philips’ devices in its latest update.

  Updated June 2, 2023

  Medical Devices

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  Illumina adds 2 medtech execs to its board, weakening Icahn’s influence

  Hologic CEO Stephen MacMillan and Edwards Lifesciences CFO Scott Ullem join just a week after chair John Thompson was ousted in a proxy battle with Icahn. 

  Medical Devices

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  AdvaMed lobbies for medtech companies to be prioritized in global supply chain

  The medtech trade group published a white paper outlining supply chain improvements needed to ensure availability of materials and parts for medical devices.

  Medical Devices

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  Illumina trains AI on primate data to estimate risk of rare variants in humans

  The results suggest AI can help improve genetic risk prediction for healthy humans, which could boost demand for Illumina’s gene sequencing devices. 

  Diagnostics

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  BD names Laura Boros president of pharmaceutical systems

  The appointment fills the vacancy at the top of the small but fast-growing division.

  Medical Devices

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  FDA hits iRhythm with warning letter over problems at heart monitor facility

  iRhythm can continue to manufacture and sell its products and does not expect the warning letter to materially affect its financial results.

  Medical Devices

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  Medtronic’s Brewer jumps to Baxter to lead patient support systems

  Julie Brewer spent nearly 17 years at Medtronic, most recently in the role of president of cardiovascular diagnostics and services.

  Updated June 1, 2023

  Medical Devices

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  Penumbra launches thrombectomy device aimed at reducing surgery, amputation

  The system, which includes a built-in algorithm, can remove large, rigid clots in the arteries that often require open surgery.

  Medical Devices

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  Masimo pushes back against activist investor it argues will cause ‘dysfunction and chaos’

  Launching a proxy battle for two board seats, Politan Capital says Masimo is underperforming its peers and making misleading public statements.

  Digital Health

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  Getinge will acquire High Purity for as much as $370M to bolster biopharma business

  The acquisition is aimed at strengthening Getinge’s position in the fast-growing area of custom single-use solutions for bioprocessing applications.

  Medical Devices

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  Patient advocacy groups urge FDA to regulate lab-developed tests if VALID Act doesn’t pass

  Legislation has been proposed in Congress to bring diagnostic tests under a single regulatory framework, but if it doesn’t pass, the FDA has authority to regulate lab-developed tests, the groups said.

  Policy & Regulation

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  MedTech Europe sets out position on cybersecurity, making case for reliance on MDR

  As the number of connected medical devices grows, the industry group argues that Europe’s new medtech regulations should remain “the primary avenue” for medical device cybersecurity.

  Digital Health

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  Microrobots powered by ultrasound show progress in drug delivery experiments in mice

  Potential applications of the technology include the treatment of painful bladder syndrome, a condition that is currently managed with multiple injections.

  Medical Devices

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  Recall of Roche partner’s COVID tests labeled as Class I

  The at-home COVID tests, made by SD Biosensor and distributed by Roche, were recalled for bacterial contamination.

  Updated May 31, 2023

  Recalls

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  Titan licenses robotic surgery intellectual property to Intuitive after failing to find buyer

  After failing to bring its surgical robot to market and getting kicked off the Nasdaq, Titan is now marketing its intellectual property.

  Medical Devices

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  Illumina accused of ‘playing delay tactics’ to push back EU decision on divesting Grail: Financial Times

  Delaying the decision to divest Grail could let Illumina sell the liquid biopsy business when the market is more favorable.

  Policy & Regulation

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  Q&A

  Friday Q&A: Stanford Biodesign’s Makower on expediting Medicare coverage for breakthrough devices

  The director and co-founder of the Stanford Byers Center for Biodesign has been urging CMS to get patients access to breakthrough devices.

  Updated May 26, 2023

  Medical Devices

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  Boston Scientific cancels $230M stent deal after regulators erect barriers to acquisition

  The Federal Trade Commission said Boston Scientific took the action in response to investigations by its staff and overseas enforcement partners.

  Medical Devices

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  Abbott’s remote heart failure monitoring system reduces hospitalizations in clinical trial

  The study is the third randomized, controlled trial globally to link CardioMEMS to a significant health benefit.

  Clinical Trials

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