The Latest

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  Opinion

  Friend, not foe: How AI will revolutionize patient care

  Artificial intelligence should be embraced to help streamline data and tackle clinician burnout, says Medtronic’s Stacey Churchwell.

  Medical Devices

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  Sponsored by Esper

  Healthtech companies dealing with complex device fleets, new report finds

  Four ways HealthTech companies are using modern solutions to manage their mission-critical devices.

  Digital Health

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  Accuray’s Suzanne Winter to lead AdvaMed radiotherapy sector

  Winter, the CEO of Accuray, succeeds Baxter’s Chris Toth as chair of the trade group’s radiation therapy sector.

  Medical Devices

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  Abbott data suggests GLP-1 drugs a ‘modest accelerator’ for CGMs: analysts

  The analysis of U.S. insurance claims found people on GLP-1 therapy wear their FreeStyle Libre sensors more.

  Medical Devices

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  Galen robot gets FDA de novo clearance for ENT surgeries

  The startup affiliated with Johns Hopkins University said it is opening a bridge round for its series B financing as it targets more applications for the robotic surgery assistant.

  Medical Devices

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  FDA posts guidance on how to simplify updates to antimicrobial resistance tests

  The advice focuses on predetermined change control plans, a mechanism the regulator sees as a way to streamline updates in multiple areas.

  Policy & Regulation

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  Artificial heart maker’s cash runway shrinks to 1 month after supply woes hurt sales

  France’s Carmat expects revenues of up to 6 million euros in the second half of the year but needs to secure financing to avoid running out of money.

  Medical Devices

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  As government shutdown looms, medical device reviews expected to continue

  The FDA could furlough nearly a fifth of its staff by Sunday if Congress doesn’t reach a funding agreement. 

  Medical Devices

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  Harbinger Health raises $140M to study blood-based cancer screening test

  The test developer will use the series B funding to complete a 10,000-subject clinical trial ahead of a planned launch in 2025.

  Clinical Trials

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  Edwards Lifesciences says it was target of surprise EU antitrust inspection

  The European Commission announced the action last week without naming the cardiovascular device company.

  Legal

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  Siemens Healthineers buys Aspekt to bolster radiation oncology services

  The company’s Varian unit sees Aspekt as complementary to its Advanced Oncology Solutions business, which provides professional and clinical services.

  Medical Devices

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  FDA finalizes guidance on cybersecurity for medical devices

  Congress granted the agency authority to deny premarket submissions that lack cybersecurity information, starting in October. 

  Medical Devices

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  Device component-maker Zeus exploring sale: Reuters

  The firm, which manufacturers catheters and other medical components, could be valued at $4 billion or more, according to the report.

  Medical Devices

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  Enovis inks $847M acquisition to boost orthopedic reconstruction business

  A Wells Fargo analyst said the deal was “much larger than what we were expecting.”

  Medical Devices

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  Clinical data from Boston Scientific and rivals could reshape pulmonary embolism market: analysts

  It is not yet clear how different approaches would benefit specific patients, creating uncertainty about which businesses will profit from the shift.

  Clinical Trials

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  Surgical robot maker Vicarious faces possible NYSE delisting

  The company’s shares could be delisted from the New York Stock Exchange if the price does not rise above $1.

  Medical Devices

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  Medtronic receives CE mark for CGM sensor, boosting challenge to Abbott and Dexcom

  Medtronic has made the sensor smaller and eliminated the need for fingersticks to calibrate the device, bringing a challenger to market leaders Abbott and Dexcom. 

  Digital Health

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  Developer of miniaturized surgical robot extends funding round

  Virtual Incision, whose surgical robot is headed to the International Space Station next year, raised $30 million in an extension of its series C round.

  Medical Devices

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  FDA shares draft medical device harmonization plan to meet MDUFA V goal

  The FDA outlined deadlines for actions it will take, including creating a mechanism for working with regulatory partners.

  Medical Devices

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  Is bigger better? McKinsey predicts the return of large medtech mergers

  The analysts argue that pressure to improve margins and become the partner of choice to hospitals favors large deals.

  Digital Health

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  Intarcia’s diabetes drug-device combo voted down again by FDA panel

  The 19-member advisory committee unanimously voted against Intarcia in the review, citing cardiovascular and kidney safety concerns.

  Medical Devices

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  Boston Scientific expects ‘dramatic shift’ to pulsed field ablation to fuel fast growth through 2026

  Management predicts PFA’s share of the AFib ablation market will climb from less than 5% now to as much as 80% in five years.

  Medical Devices

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  Hologic allies with Bayer to support uptake of contrast-enhanced mammography

  The companies will provide a product package and training intended to support adoption of the imaging technique.

  Medical Devices

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  CMR Surgical secures $165M for its robot expansion

  The new funding will also support product innovation efforts as the company builds a position in the fast-growing robotic surgery market.

  Updated Sept. 21, 2023

  Medical Devices

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  Limited resources constrain federal oversight of medical device ads, GAO finds

  U.S. agencies took 322 enforcement actions related to medtech advertising between 2018 and 2022.

  Medical Devices

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  Hamilton Medical recalls ventilators for control board problem

  The issue can cause a short circuit or lead the capacitor to lose function, interrupting ventilation.

  Medical Devices

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