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.
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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.
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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.
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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.
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Retrieved from Galen Robotics on September 27, 2023
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.”
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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.
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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.
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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.
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Retrieved from University of Nebraska-Lincoln on September 25, 2023
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.
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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.
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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.
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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.
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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.
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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.
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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 -
"Government Accountability Office Building" by kafka4prez is licensed under CC BY-SA 2.0
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.
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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.