Medical Devices: Page 49

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    J&J starts trial of pulsed field ablation catheter with mapping feedback

    Omnypulse expands J&J’s portfolio of investigational devices with a catheter that gathers contact force data.

    By • Sept. 19, 2023
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    Courtesy of U.S. Food and Drug Administration
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    FDA releases draft guidance for studying weight loss devices

    The documents arrive amid questions about whether new medicines will cut demand for weight loss procedures.

    By • Sept. 19, 2023
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    Trendline

    Top 5 stories from MedTech Dive

    From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
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    MedTech Europe says MDR, IVDR framework needs ‘structural reform’

    Patients may face delayed access to treatments unless changes are made to the new regulatory system, 35 European trade groups warned in an open letter.

    By • Sept. 18, 2023
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    Sara Silbiger via Getty Images
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    FDA finalizes breakthrough device changes to target health inequities

    The proposals received positive feedback from groups including AdvaMed, leading the FDA to finalize the changes with only minor revisions.

    By • Sept. 18, 2023
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    Beacon Biosignals receives FDA clearance for sleep tracking headband

    The company’s at-home device, the Dreem 3S, has six EEG electrodes to capture brain activity.

    By • Sept. 18, 2023
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    Permission granted by Bigfoot Biomedical
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    Q&A

    Bigfoot CEO talks Abbott acquisition, future of diabetes tech

    Jeffrey Brewer hopes to see more integrated solutions for people with diabetes, starting with the company’s partnership with Abbott.

    By • Sept. 15, 2023
  • Chinese President Xi Jinping wears a suit, tie and name tag and is pictured seated at a desk and holding a pen.
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    Lintau Zhang via Getty Images
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    Hospital, lab equipment makers brace for China demand slowdown

    Chinese purchases represent 10% to 20% of revenues on average for leading companies in the life science tools sector, according to Jefferies research.

    By • Sept. 15, 2023
  • Johnson & Johnson's new logo is seen on an office lobby wall.
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    Courtesy of Johnson & Johnson
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    J&J to phase out Janssen name in corporate rebrand

    Janssen will be recast as Johnson & Johnson Innovative Medicine, while the company’s medical device business will remain Johnson & Johnson MedTech.

    By Ned Pagliarulo • Sept. 15, 2023
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    Courtesy of GE HealthCare
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    GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI

    The organizations will collaborate on the application of AI to MRI and the automation of diagnostic and interventional ultrasound.

    By • Sept. 15, 2023
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    dzika_mrowka via Getty Images
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    Insulin pump-makers grapple with questions about GLP-1s

    The new class of weight loss drugs has caused a stock selloff, but is unlikely to “meaningfully change the long-term outlook for diabetes,” analysts wrote.

    By • Sept. 14, 2023
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    AlexeyKamenskiy via Getty Images
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    FTC closes probe of Resonetics’ $900M medical nitinol purchase

    The acquisition would give Resonetics a leading supplier of the alloy for the medical device industry.

    By • Sept. 14, 2023
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    Permission granted by Abbott Laboratories
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    Abbott’s neurostimulator recall, with 73 injuries reported, deemed Class I by FDA

    The company contacted customers in July after receiving complaints from patients who were unable to exit the devices’ MRI mode.

    By • Sept. 14, 2023
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    Sarah Silbiger via Getty Images
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    FDA finalizes biocompatibility guidance for devices that touch the skin

    The agency chose not to make some major requested revisions, such as including metals in the scope of the guidance.

    By • Sept. 14, 2023
  • Akili's digital therapeutic, EndeavorRx, involves navigating obstacles in different courses. It's intended to improve attention.
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    Courtesy of Akili Interactive
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    Akili cuts 40% of workforce, plans shift to non-prescription model

    The digital therapeutics company expects to extend its cash runway into 2025 with the changes.

    By • Sept. 13, 2023
  • Catherine Burzik is wearing a jacket with a black collar.
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    Permission granted by Orthofix
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    Orthofix fires CEO, CFO after investigation finds misconduct

    The executives engaged in “repeated inappropriate and offensive conduct” inconsistent with the company’s values, Orthofix said.

    By • Sept. 13, 2023
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    Stock via Getty Images
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    FDA finalizes combination product guidance 7 years after sharing draft

    AdvaMed called overlapping human factor requirements of the draft guidance “overly burdensome.”

    By • Sept. 13, 2023
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    Sarah Silbiger via Getty Images
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    TB deaths prompt FDA warning on reducing transmission risk

    The agency outlined risk mitigation strategies for cell and tissue products after two recipients of bone matrix products died.

    By • Sept. 13, 2023
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    iStock via Getty Images
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    CMS digs deeper into impact of proposed breakthrough device pathway in JAMA paper

    The article discusses what the TCET pathway will mean for products at different stages of the life cycle.

    By • Sept. 12, 2023
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    Getty Images via Getty Images
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    Bausch + Lomb seeks funding for $1.75B eye drop acquisition from Novartis

    Fitch Ratings called the deal to buy the Xiidra treatment “strategically sound” even as the company’s plan to fund it would increase its leverage.

    By • Sept. 12, 2023
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    Nastassia Samal via Getty Images
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    Centinel Spine to sell fusion business, focus on disc replacement

    Switzerland’s Silony Medical, which is buying the technology, sees itself as a challenger to “big medtech” in spinal fusion.

    By • Sept. 11, 2023
  • Exterior of Sterigenics Fort Worth, TX, facility with trucks
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    Courtesy of Sterigenics
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    Sterigenics’ $408M ethylene oxide settlement removes ‘most problematic’ lawsuits: analysts

    Remaining lawsuits pose less of a threat to the medical device sterilizer, and tighter emissions standards seem achievable, KeyBanc analysts wrote. 

    By • Sept. 8, 2023
  • Intuitive Surgical's Tony Jarc is wearing a dark blue jacket and white shirt in a corporate head shot.
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    Permission granted by Intuitive Surgical
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    Q&A

    Intuitive’s Tony Jarc on how AI is improving robotic surgery

    The company aims to help surgeons achieve better results for patients and hospitals.

    By • Sept. 8, 2023
  • Boston Scientific's Farapulse pulsed field ablation PFA generator and catheter
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    Permission granted by Boston Scientific
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    PFA procedures expected to rise after Boston Scientific study results

    Analysts estimate the technology could be used in up to half of all cardiac ablation cases in a few years. 

    By • Sept. 8, 2023
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    Bayer faces Essure lawsuit after UK court clears 200 women to claim for damages

    Bayer has vowed to defend itself “vigorously” against claims that could cost the company more than $12 million in damages.

    By • Sept. 8, 2023
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    Permission granted by Zimmer Biomet
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    Zimmer Biomet promotes 3 executives

    The appointments come less than a month after the company elevated Ivan Tornos to the CEO position.

    By • Sept. 7, 2023