Medical Devices: Page 52

  • Elon Musk Speaks At Satellite Conference In Washington, DC
    Image attribution tooltip
    Win McNamee / staff via Getty Images
    Image attribution tooltip

    Elon Musk’s brain implant company raises $280M to fund clinical trials

    Peter Thiel's venture capital firm led the investment weeks after Neuralink secured clearance to study its device in humans.

    By • Aug. 9, 2023
  • a lab worker with testubes of blood
    Image attribution tooltip
    Courtesy of GuardantHealth
    Image attribution tooltip

    Guardant, Illumina agree to end litigation, extend commercial partnership

    The two sides will now renew a long-term collaboration to advance cancer research, Guardant said.

    By • Aug. 8, 2023
  • the FDA Headquarters Explore the Trendline➔
    Image attribution tooltip
    Sara Silbiger via Getty Images
    Image attribution tooltip
    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
  • Abbott company sign outside
    Image attribution tooltip

    Courtesy of Abbott Laboratories

    Image attribution tooltip

    Abbott lands FDA clearance of Alinity complete blood count system

    The company claims the device uses less floor space and has one of the highest throughputs as it competes with diagnostic systems made by Beckman Coulter and Siemens Healthineers.

    By • Aug. 8, 2023
  • Wooden brown judge gavel on the table, with an book opened and blurred in the background.
    Image attribution tooltip
    nathaphat/iStock via Getty Images
    Image attribution tooltip

    Appeals court overturns ruling in Axonics-Medtronic neurostim patent dispute

    The court said the patent board’s “refusal to consider the new arguments and evidence was erroneous.” 

    By • Aug. 8, 2023
  • A straw-shaped device with a metal tip
    Image attribution tooltip
    Permission granted by Biosense Webster
    Image attribution tooltip

    J&J subsidiary gains approval for heart ablation devices to use without fluoroscopy

    The expanded label could limit exposure to radiation while patients are treated for heart arrhythmias.

    By • Aug. 7, 2023
  • Rendering of a spiral-shaped catheter with four electrodes
    Image attribution tooltip
    Permission granted by Medtronic
    Image attribution tooltip

    Medtronic expected to prevail at FDA renal denervation vote despite data doubts: analysts

    Needham analysts predict the experts will vote in favor of Medtronic and put the device on track to target a $1 billion-plus market.

    By • Aug. 7, 2023
  • Anne-Françoise Nesmes, CFO of Smith & Nephew, is wearing a pink jacket.
    Image attribution tooltip
    Courtesy of Smith & Nephew
    Image attribution tooltip

    Anne-Françoise Nesmes to step down as Smith+Nephew CFO next year

    The announcement comes as Smith+Nephew raised its forecast for the year to a 6% to 7% revenue increase, due to more favorable market conditions. 

    By • Aug. 7, 2023
  • An x-ray image of a person's pelvis shows a hip replacement on the left side.
    Image attribution tooltip
    ChooChin via Getty Images
    Image attribution tooltip

    Stryker raises earnings forecast as procedures return to pre-pandemic levels

    The company expects elevated procedure demand to continue into 2024 due to surgery backlogs.

    By • Aug. 4, 2023
  • A photo of Ben Sexson
    Image attribution tooltip
    Permission granted by Monogram Orthopedics
    Image attribution tooltip

    Q&A: How Monogram’s CEO plans to disrupt robotic joint replacement surgery

    The robot developer’s CEO, Benjamin Sexson, tells MedTech Dive why he believes the orthopedics market needs a fresh approach to joint reconstruction.

    By • Aug. 4, 2023
  • Illustration of a blood clot blocking red blood cells within an artery or a vein.
    Image attribution tooltip
    libre de droit via Getty Images
    Image attribution tooltip

    Penumbra says stroke device delayed at least 12 months due to FDA request

    The setback stalls “a meaningful new product catalyst,” but the growth of Penumbra’s other devices could cushion the impact, analysts said.

    By • Aug. 4, 2023
  • Outset Medical's Tablo Hemodialysis System.
    Image attribution tooltip
    Courtesy of Outset Medical
    Image attribution tooltip

    Outset pauses shipments of dialysis accessory after FDA warning letter, denting sales outlook

    The halt prompted the company to predict it will now hit the bottom end of its full-year revenue range, a revision that surprised some analysts.

    By • Aug. 4, 2023
  • Becton Dickinson logo
    Image attribution tooltip
    Permission granted by Becton Dickinson
    Image attribution tooltip

    BD prepares for relaunch of Alaris pump, raises revenue forecast

    The pump relaunch isn’t expected to contribute much to this year’s revenue, but could help Becton Dickinson reach its long-term financial goals. 

    By • Aug. 3, 2023
  • Physician holding Aveir VR LP with gloved hand
    Image attribution tooltip
    Courtesy of Abbott
    Image attribution tooltip

    CMS inpatient final rule will have muted impact on medtech companies, analysts say

    The CMS disclosed add-on payments that will continue in 2024 and named products that received approval under the breakthrough devices pathway.

    By • Aug. 3, 2023
  • A hospital patient receives medication through an IV in their hand.
    Image attribution tooltip
    Boyloso via Getty Images
    Image attribution tooltip

    Baxter recalls infusion pumps over risk of false alarms

    Baxter made a software fix last year after it found pumps weren't issuing an occlusion alarm. Now, the devices might issue alarms even when there isn't a blockage.

    By • Aug. 2, 2023
  • The Federal Trade Commission headquarters is pictured in Washington, D.C. The agency's proposed noncompete ban may face legal challenges on several grounds.
    Image attribution tooltip
    RiverNorthPhotography via Getty Images
    Image attribution tooltip

    Cooper scraps $875M takeover of Cook Medical business after FTC investigation

    The FTC said ending the planned acquisition “ensures that critical reproductive health markets remain competitive.” 

    By • Aug. 2, 2023
  • Persons in physician garb standing around Siemens Cios Spin Endobronchial imaging machine
    Image attribution tooltip
    Retrieved from Siemsens Website on July 01, 2022
    Image attribution tooltip

    Varian logistics slow growth at Siemens Healthineers in Q3

    Healthineers has worked through some logistics problems but now faces a race to install Varian equipment at customer sites. 

    By • Aug. 2, 2023
  • Close up of bags of blood in front of a device with a rounded lid.
    Image attribution tooltip
    Courtesy of Terumo BCT
    Image attribution tooltip

    Terumo receives FDA clearance for automated whole blood processing system

    The device automates additional steps needed to separate platelets from the rest of the blood, giving blood centers more capacity.

    By • Aug. 1, 2023
  • Abbott company sign outside
    Image attribution tooltip

    Courtesy of Abbott Laboratories

    Image attribution tooltip

    Abbott pulls Trifecta heart valves from US market over deterioration rate

    The action removes a rival to Edwards Lifesciences and Medtronic for the surgical aortic valve replacement market.

    By • Aug. 1, 2023
  • Vicarious Surgical plans to seek de novo clearance for its surgical robot.
    Image attribution tooltip
    Permission granted by Vicarious Surgical
    Image attribution tooltip

    Vicarious expects to perform first human procedure with robot next year

    The company, after disclosing layoffs in February, said it has gained clarity on its regulatory pathway following pre-submission meetings with the FDA.

    By • July 31, 2023
  • A surgeon holds a piece of surgical mesh for hernia and abdominal wall surgery.
    Image attribution tooltip
    Courtesy of Integra
    Image attribution tooltip

    Integra warns impact of plant closure will continue into 2024, with delays possible

    Management has built a buffer into the plan but cautioned unforeseen events could cause its timeline to slip.

    By • July 31, 2023
  • fda
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    GE HealthCare oxygen sensor recall gets Class I label from FDA

    GE warned that the sensors can limit the effectiveness of cardiac defibrillation, expose patients to electrical currents, or give inaccurate blood oxygen readings. 

    By • July 31, 2023
  • Thermo Fisher Scientific
    Image attribution tooltip
    Courtesy of Thermo Fisher Scientific
    Image attribution tooltip

    Thermo Fisher eyes $450M in cost cuts due to slowing demand

    The pullback in spending will include layoffs and lower investments in some areas of the business, company executives said.

    By • July 28, 2023
  • the FDA Headquarters
    Image attribution tooltip
    Sara Silbiger via Getty Images
    Image attribution tooltip

    FDA shares draft guidance on studying medtech treatments for opioid use disorder

    The FDA aims to address challenges including inaccurate self-reported drug use, missing data and the need to show the durability of the treatment.

    By • July 28, 2023
  • The Dexcom G7 Continuous Glucose Monitoring (CGM) System
    Image attribution tooltip
    Courtesy of Dexcom
    Image attribution tooltip

    Dexcom hails CGM share gains as driver of 25% revenue growth in Q2

    International market share gains and expanding coverage in the U.S. led the CGM maker to raise its revenue forecast for 2023.

    By • July 28, 2023
  • Abbott company sign outside
    Image attribution tooltip

    Courtesy of Abbott Laboratories

    Image attribution tooltip

    Abbott recall of heart catheter categorized as Class I event

    Abbott plans to win approval for a modified steerable product and bring it to market as a replacement for the recalled device.

    By • July 27, 2023