Medical Devices: Page 67


  • Surgeons and healthcare workers in an operating room
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    Gorodenkoff via Getty Images
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    Medtech trends in 2023

    Medtech M&A outlook for 2023: Spinoffs, China exits, AI opportunities poised to spur deal rebound

    Companies flush with cash are looking for good investments and innovative products that can reduce procedure costs, industry observers say.

    By Peter Green • Jan. 31, 2023
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    Danielle Ternes
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    FDA device center’s 2022 report reveals 37% drop in annual breakthrough designations

    The annual report also highlighted the CDRH’s work on pulse oximeters, Philips’ recall of sleep and respiratory devices, cybersecurity and artificial intelligence.

    By Jan. 31, 2023
  • the FDA Headquarters Explore the Trendline
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    Sara Silbiger via Getty Images
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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
  • A sign for the Food and Drug Administration is seen on July 20, 2020 in Maryland.
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    Sarah Silbiger via Getty Images
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    Medtronic recalls 22,000 hemodialysis catheters for potential hub defect

    The FDA reported two injuries tied to the problem, which could cause leaks across the tubes of the implanted catheters and produce blood clots.

    By Jan. 30, 2023
  • Elements of LivaNova’s LifeSPARC circulatory support system
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    Courtesy of https://www.livanova.com/advanced-circulatory-support/en-us
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    LivaNova recalls circulatory support device for software fix

    The update is intended to fix a malfunction that could cause its LifeSPARC pump to stop working. 

    By Jan. 30, 2023
  • CEO Peter Arduini (L) and CFO Helmut Zodl (R) of GE Healthcare after a presentation to investors at Times Square in New York City.
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    Peter S Green/MedTech Dive
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    GE HealthCare posts revenue growth in last quarter before spinoff on imaging, ultrasound units

    The company benefitted from “robust end-market demand, improved pricing, and easing supply chain pressures” in the period.

    By Peter Green • Jan. 30, 2023
  • A Philips factory
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    Patrik Stollarz / Staff via Getty Images
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    Philips will cut 6,000 more jobs to reduce costs after company swung to net loss in Q4

    New CEO Roy Jakobs said Philips has been spreading its resources too thinly and “can't and won't be selling everything everywhere anymore.”

    By Jan. 30, 2023
  • Professional photo of Elizabeth Gasser
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    Permission granted by Tandem Diabetes Care
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    Q&A

    Friday Q&A: Tandem’s chief strategy officer talks tubeless pumps, Type 2 plans

    Elizabeth Gasser also discusses the company’s recent acquisition of AMF Medical as well as how it factors environmental impact into device design.

    By Jan. 27, 2023
  • A headshot of ResMed CEO Mick Farrell.
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    Permission granted by ResMed
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    ResMed quarterly revenue beats estimates as supply chain woes ease

    Demand for CPAP devices and respirators remains strong as the company expects to pick up additional market share from rival Philips, and demand grows for its medical SaaS products.

    By Jan. 27, 2023
  • A patient with a Rockley Photonics wearable
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    Courtesy of Rockley Photonics
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    Medtronic wearable partner files for bankruptcy but plans to continue ‘without interruption’

    Rockley Photonics works with two of the top five medtech companies, plus six leading smart watch makers including Apple, but has run into financial problems.

    By Jan. 27, 2023
  • A headshot of Jennifer Samproni
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    Courtesy of Flex
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    Opinion

    Why medical device designers need to become more agile — and how they can do it

    To stay competitive, medtech firms must center manufacturing in business optimization plans, while embracing a design-to-value approach, says Jennifer Samproni, Flex’s chief technology officer for its Health Solutions division.

    By Jennifer Samproni • Jan. 26, 2023
  • The headquarters of the Food and Drug Administration
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    Sarah Silbiger via Getty Images
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    Medtech trends in 2023

    Medtech regulation outlook in 2023: Faster approvals among priorities as AI moves to fore

    Leaders in the medtech field weigh in on the prospects and challenges for product regulation in 2023.

    By Peter Green • Updated Jan. 26, 2023
  • A biobot from the University of Illinois
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    Courtesy of University of Illinois/Yongdeok Kim
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    Researchers create remote-controlled biological robot that could eventually be used in surgery

    The design allows the integration of sensors and other components that could eventually equip the robots to detect biomarkers of disease, carry out biopsies or perform surgery.

    By Jan. 26, 2023
  • A Getinge technician assembling a heart assist device in a cleanroom
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    Courtesy of Getinge
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    Getinge heart pump gets third Class I recall after patient death

    Customers were alerted to problems with Cardiosave devices late last year after Getinge received complaints about an issue linked to four serious injuries and one death.

    By Jan. 26, 2023
  • Abbott company sign outside
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    Courtesy of Abbott Laboratories

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    Abbott sees ‘signs of stability’ for 2023 as hospital staffing, supply chain improves

    While the company continues to grapple with supply shortages and procedure restrictions, it sold more COVID-19 tests than expected in the fourth quarter.

    By Jan. 25, 2023
  • Programming scripts on laptop monitor, unauthorized remote hacking of server
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    Motortion via Getty Images
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    Cybersecurity ‘more critical than ever’ in era of connected care: BD

    The device maker’s annual report on the state of healthcare cybersecurity calls for better transparency and coordination across the industry.

    By Jan. 25, 2023
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    VCG / Stringer via Getty Images
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    Intuitive Q4 profit slips on costs to boost share of robotic surgery market

    The investment in innovation comes as Intuitive tries to maintain its dominant position in the face of rivals including Johnson & Johnson and Medtronic.

    By Jan. 25, 2023
  • 3M headquarters in Minnesota
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    Courtesy of 3M.

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    3M’s healthcare unit Q4 earnings drop on nurse shortages, falling hospital budgets

    Elective healthcare procedure volumes were about 90% of pre-COVID levels.

    By Jan. 25, 2023
  • Band-Aid box
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    Courtesy of Johnson&Johnson
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    J&J sees Abiomed adding to revenue in 2024; Q4 sales drop

    Foreign-exchange fluctuations helped curb revenue in the period.

    By Peter Green • Jan. 24, 2023
  • A phone-like device shows a bolus insulin measurement, with a white, U-shaped device to the right.
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    Courtesy of Insulet Corp.
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    Insulet reports personal-data leak of 29,000 insulin pump customers

    In a recall communication to users, Insulet shared information with its website performance and marketing partners through cookies and other trackers embedded in its website. 

    By Jan. 24, 2023
  • A Medtronic HVAD pump in the palm of a human hand
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    Courtesy of https://news.medtronic.com/Left-Ventricular-Assist-Device-For-Advanced-Heart-Failure#assets_34137_10-122:19299
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    Medtronic asks HVAD users to return batteries with welding defects

    The recall is one of several related to battery issues after the heart pump was pulled from the market.

    By Jan. 23, 2023
  • Michael Snyder and his lab team at Stanford in a group photo
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    Courtesy of Stanford University
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    Q&A

    3 questions for Michael Snyder, lead inventor of single-drop blood test

    The head of a Stanford research team says the test differs from Theranos' defunct product because "ours works."

    By Peter Green • Jan. 23, 2023
  • EPA map of cancer risk at Ethylene plant of Benton Dickson
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    EPA. (2022). "https://www.epa.gov/hazardous-air-pollutants-ethylene-oxide/forms/columbus-nebraska-becton-dickinson-pharmaceutical" [Photo]. Retrieved from EPA.gov.
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    Ethylene oxide regulation may disrupt device supply, AdvaMed warns White House

    The trade group has asked President Joe Biden to consider the potential threat to patient care if facilities are shut down.

    By Jan. 23, 2023
  • Exterior of FDA headquarters
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    Courtesy of U.S. Food and Drug Administration
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    FDA demands additional data on Abbott rival to Medtronic balloon, setting back approval timeline

    Abbott’s partner Surmodics is “evaluating options” to reduce its spending while preparing a response to the regulator’s requests.

    By Jan. 20, 2023
  • Professional photo of Kevin Sayer
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    Permission granted by Dexcom
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    Q&A

    Dexcom CEO discusses 2023 plans, expanding to more patients with Type 2 diabetes

    MedTech Dive caught up with Kevin Sayer for a conversation about forthcoming product launches and long-term plans to expand CGMs to a broader group of patients. 

    By Updated Jan. 20, 2023
  • Philips CPAP machine
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    N/A via Getty Images
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    Medtech hazards: Problems with Philips’ recall put safety of home-use devices at top of danger list

    Patient safety group ECRI is challenging manufacturers to provide easy-to-follow device registration instructions and write simply worded recall notices.

    By Jan. 19, 2023