Medical Devices: Page 54

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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    AdvaMed called overlapping human factor requirements of the draft guidance “overly burdensome.”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
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
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    Trendline

    New medical devices are reshaping the medtech industry

    From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

    By MedTech Dive staff
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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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    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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    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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    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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    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
  • Philips CPAP machine
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    Philips reaches settlement in US respiratory device litigation

    The company will pay more than $479 million to resolve all economic loss claims. The settlement does not include injury or medical monitoring claims. 

    By • Sept. 7, 2023
  • Exterior of FDA headquarters
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    Courtesy of U.S. Food and Drug Administration
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    FDA proposes 3 guidances to improve 510(k) clearance process

    The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.

    By • Sept. 7, 2023
  • Watchman Flx Left Atrial Appendage Closure Device
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    Courtesy of Boston Scientific
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    Boston Scientific gets FDA nod for latest device in fast-growing Watchman franchise

    Analysts at RBC Capital Markets called the Watchman FLX Pro approval an “incremental positive” for Boston Scientific.

    By • Sept. 7, 2023
  • Graham Felstead sits in front of a computer screen.
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    Permission granted by Synchron
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    Synchron brain-computer interface implanted in first 6 US patients

    The device is intended to give people with severe paralysis the ability to use their thoughts to perform everyday functions, such as online communications, hands-free.

    By • Sept. 6, 2023
  • White and black pen caps read "120 mg/dl" and a smartphone app says "Glucose in range."
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    Permission granted by Bigfoot Biomedical
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    Abbott to buy smart insulin pen cap maker Bigfoot

    The planned acquisition could shift patients interested in smart pens to Abbott’s Libre CGMs, an analyst wrote.

    By • Sept. 6, 2023
  • Thaysen is pictured in a suit and tie.
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    Permission granted by Illumina
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    Illumina names Agilent’s Jacob Thaysen as its next CEO

    The appointment comes less than three months after former CEO Francis deSouza stepped down following a proxy battle.

    By • Sept. 5, 2023
  • A phone app shows a chart with current glucose levels, next to a pen-shaped device.
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    Courtesy of Medtronic
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    Medtronic sued for allegedly sharing ‘treasure trove’ of diabetes patient data with Google

    The plaintiff said disclosures to Google are “particularly problematic” because his use of Gmail meant his personal information was “automatically linked to his real identity.”

    By • Sept. 5, 2023
  • A photo of a robotic system used to perform lung biopsy surgery.
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    Permission granted by Noah Medical
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    Noah Medical lung biopsy robot exceeds expectations in first-in-human trial

    The startup presented early data on its FDA-cleared system at a meeting of pulmonologists in Chicago.

    By • Sept. 1, 2023
  • Multiple black-and-white scans of the lumbar spine next to each other.
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    Spine volumes to grow 6.5% next year as post-pandemic boost continues: analysts

    Use of robotic systems in spine surgeries also is on the rise, according to the latest poll by BTIG.

    By • Sept. 1, 2023
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    Permission granted by ZimVie
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    Q&A

    ZimVie’s Rebecca Whitney sizes up the competition in cervical disc implants

    The company is bringing new products to market as it faces more challengers in cervical disc replacement and tethering for scoliosis.

    By • Sept. 1, 2023
  • A black, square device with tubing connected to a patch is next to a phone that says "Beta Bionics" and another patch that says DexcomG6
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    Courtesy of Beta Bionics
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    Beta Bionics raises $100M to challenge Medtronic, Tandem for automated insulin dosing market

    The company’s iLet Bionic Pancreas automates insulin dosing without requiring mealtime carb counting. 

    By • Sept. 1, 2023
  • Abbott Laboratories
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    Courtesy of Abbott
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    Abbott study shows benefits of OCT imaging in stent placement

    Optical coherence tomography improved doctors’ ability to place stents, but the study did not meet its primary goal for reducing a composite of deaths, heart attacks and repeat procedures. 

    By • Aug. 31, 2023
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    UK regulators name 3 approved bodies to ease device certification bottleneck

    A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.”

    By • Aug. 31, 2023
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    Courtesy of Hamilton Medical
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    Hamilton Medical’s urgent ventilator notice deemed Class I recall by FDA

    The company contacted customers in June after learning that long-term use of the devices could cause them to stop providing active ventilation.

    By • Aug. 31, 2023
  • A person speaks in front of a screen showing four cards that read: Lingo Glucose, Lingo Ketone, Lingo Lactate and Lingo Alcohol
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    Ethan Miller via Getty Images
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    Deep Dive

    Why medtech firms are putting diabetes tech in consumer devices

    As Abbott develops a line of wearable wellness devices, and Dexcom makes a CGM for people with diabetes who don’t take insulin, both companies are turning to new users for future growth.

    By • Updated Aug. 31, 2023