Medical Devices: Page 68


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    Coloplast to pay $1.2B upfront to buy fish skin wound care business Kerecis

    Kerecis’ fish skin biologic, which aids tissue regeneration, helped drive the company’s sales to $74.5 million last year.

    By July 10, 2023
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    Permission granted by Medtronic
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    Medtronic secures Medicare coverage for MiniMed 780G insulin pump

    Medtronic has begun processing orders and will start shipping devices over the next few weeks.

    By July 10, 2023
  • Intuitive Surgical's da Vinci 5 robotic system. Explore the Trendline
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    Courtesy of Intuitive Surgical
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    Trendline

    Top 5 stories from MedTech Dive

    From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

    By MedTech Dive staff
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    Permission granted by Penumbra
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    Q&A

    Q&A: Penumbra CEO Adam Elsesser says new devices will drive changes in clot treatment

    Penumbra has launched two devices that use computers to control suction of blood clots. That’s helped the company convert some surgeons from traditional methods of clot removal, like open surgery or drugs.

    By July 7, 2023
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    BD to shed 60 jobs as COVID demand, diabetes spinoff affect manufacturing plant

    The cuts are the latest in a wave of workforce reductions by medtech companies including Abbott Laboratories, Cook Medical, Illumina and Thermo Fisher Scientific.

    By July 7, 2023
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    Illumina’s ‘inevitable’ split from Grail likely by mid-2024, analysts say

    Canaccord Genuity analysts, commenting on a Financial Times article predicting a record EU fine against the DNA sequencer for closing its Grail acquisition, said it looks “almost certain” regulators will force a divestiture.

    By July 6, 2023
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    Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
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    FTC intervenes to correct Medtronic’s ‘erroneous assertions’ in antitrust case

    The FTC filed an amicus brief because it said Medtronic made “wrong” arguments with “broad implications for antitrust enforcement.”

    By July 6, 2023
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    Adam Berry via Getty Images
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    European guidelines offer support for renal denervation in hypertension, boosting Medtronic, ReCor

    Medtronic hailed the updated guidelines as a “turning point” for the use of renal denervation in treating high blood pressure.

    By July 6, 2023
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    Medtronic identifies cybersecurity vulnerability in cardiac data system

    Cyber attackers could exploit the vulnerability if healthcare organizations have enabled its optional messaging service, the device maker said.

    By July 5, 2023
  • A battery that says "AAA" on the left, is compared to two small, cylindrical devices on the right.
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    Courtesy of Abbott
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    Abbott secures FDA approval for dual-chamber leadless pacemaker

    With the new device, Abbott is ramping up competition with Medtronic in the leadless pacemaker market.

    By July 5, 2023
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    Courtesy of U.S. Food and Drug Administration
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    Startup’s fast-acting wound treatment gel gets FDA nod for use in humans

    Cresilon raised $25 million last year as part of a push to expand its wound-gel product for animals into human health.

    By July 5, 2023
  • The Dexcom G7 Continuous Glucose Monitoring (CGM) System
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    Courtesy of Dexcom
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    Q&A

    Q&A: Dexcom’s Lawver shares strategy behind CGM for non-insulin users

    The continuous glucose monitor in development for people with Type 2 diabetes who don’t take insulin could expand the CGM market to 25 million more people in the U.S., the company’s new chief commercial officer said.

    By June 30, 2023
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    Mario Tama via Getty Images
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    Diabetes remains fastest-growing medtech market despite some risk from new drugs: analysts

    The medicines could apply “short-lived pressures” to medtech companies by affecting the use of insulin, Mizuho analysts say. 

    By June 30, 2023
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    EU MDR costs could cause device shortages for children, medical groups warn

    The cost of certification under new medical device regulations in Europe is a barrier to manufacturers that make devices for small groups of patients, medical associations said.

    By June 29, 2023
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    Retrieved from Istock.
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    FDA seeks feedback on technologies that can enable healthcare at home

    The FDA is asking the medtech industry for input on how the agency can support development of devices for use in non-clinical care settings and by diverse patient populations.

    By June 29, 2023
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    Sarah Silbiger via Getty Images
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    FDA repeats restrictions on NuVasive limb-lengthening device after clearing pediatric use

    The agency in March cleared NuVasive to market its Precice limb-lengthening system for use in the femur and tibia of children aged 12 years and up.

    By June 29, 2023
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    Mario Tama via Getty Images
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    Former J&J sales rep indicted on charges of defrauding Boston hospital

    The former J&J employee is accused of bilking the hospital out of hundreds of thousands of dollars’ worth of spine products.

    By June 28, 2023
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    Sarah Silbiger/Getty Images via Getty Images
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    Teleflex recall of separating vascular catheters labeled Class I event

    The company began the recall in May after receiving 83 complaints, including 18 reports of injuries, related to the fault.

    By June 28, 2023
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    Invacare names Kai Zhu as CFO

    The promotion positions Zhu to help lead the manufacturer of non-acute care medical equipment as it works to recover from a bankruptcy filing.

    By June 28, 2023
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    Brian Tucker
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    Proposed EtO limits garner criticism from device industry, praise from occupational health groups

    Lobbyists representing medical device companies say the proposed policy would reduce capacity at commercial sterilizers by as much as 50%.

    By June 27, 2023
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    Permission granted by Politan Capital Management
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    Masimo shareholders elect activist investor’s two board candidates

    The vote approving Politan Capital’s nominees is “a clear mandate from shareholders that significant change is needed at Masimo,” said newly elected director Quentin Koffey.

    By Updated June 27, 2023
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    Restor3d inks Conformis buyout, adding hip and knee implants to portfolio

    Restor3d, which makes 3D-printed devices for spine, ankle and upper extremity procedures, is buying Conformis at a 96% premium. 

    By June 27, 2023
  • A close-up shot of a woman's hands, handling a syringe of insulin.
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    Getty Images
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    More than 1 billion people could have diabetes by 2050, study says

    A pair of studies published in the Lancet show that spending on diabetes care is expected to rise, but more work is needed to address structural inequities that affect access to treatment.

    By June 26, 2023
  • From left to right: a white cylindrical device with a cord, a smartphone app showing blood glucose levels, a square device showing a blood glucose reading, and a white circular device.
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    Permission granted by Medtronic
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    Medtronic links 780G insulin pump to benefits in kids as it works to grow sales

    A clinical trial found adolescent users of the pump can achieve improved blood glucose control without precisely counting carbohydrates.

    By June 26, 2023
  • The Dexcom G7 Continuous Glucose Monitoring (CGM) System
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    Courtesy of Dexcom
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    Dexcom targets 25M Americans with new CGM aimed at non-insulin-using diabetics

    The device will last for 15 days, include a cash-pay option and come with software designed for the needs of people who are yet to require insulin.

    By June 26, 2023
  • Masimo CEO Joe Kiani looks over the countryside
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    Courtesy of BusinessWire/Masimo
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    Deep Dive

    Showdown at Masimo: Proxy battle targets CEO Kiani’s leadership, board

    Shareholders are voting on whether to add investor Politan Capital’s picks to the board of the pulse oximeter maker, a move that could change the company’s direction.

    By June 23, 2023