Medical Devices: Page 51

  • Professional photo of Ivan Tornos
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    Permission granted by Zimmer Biomet
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    ‘Business as usual’ at Zimmer Biomet despite sudden CEO change

    Incoming Chief Executive Ivan Tornos could accelerate the orthopedics company’s turnaround through acquisitions and by expanding its margins, analysts said.

    By • Aug. 24, 2023
  • Rendering of a spiral-shaped catheter with four electrodes
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    Permission granted by Medtronic
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    Medtronic renal denervation device hits setback at FDA panel

    The agency’s outside advisers found the risks of the procedure to lower blood pressure outweighed the benefits in a narrow vote.

    By • Aug. 24, 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 building with a windowed wall and a sign that reads "Dräger"
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    Courtesy of Draeger
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    Draeger’s ventilator sound insulation recall triggers FDA Class I notification

    The company found concentrations of a potentially carcinogenic foam component were above acceptable levels for children.

    By • Aug. 24, 2023
  • A rendering of Recor's Paradise renal denervation catheter within an artery. The red circle indicates the heat generated from the ultrasound energy in the tissue delivering energy within the artery.
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    Courtesy of Recor
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    Recor wins FDA panel’s backing for high blood pressure device

    The advisers found the company’s renal denervation system is safe and effective, but several panelists expressed concern about the long-term durability of the treatment.

    By • Aug. 23, 2023
  • The logo of German pharmaceuticals and chemicals giant Bayer stands over Bayer corporate offices on September 14, 2016 in Berlin, Germany.
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    Sean Gallup via Getty Images
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    Bayer inks deal to commercialize Mahana’s prescription digital therapeutics

    The multimillion-dollar distribution and marketing partnership comes amid a decline in funding for prescription digital therapeutic companies. 

    By • Aug. 23, 2023
  • A person holds a surgical tool while monitoring a robotic arm over a patient's abdomen.
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    Courtesy of Levita Magnetics
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    Levita’s surgeon-controlled arm for magnetic procedures gains 510(k) clearance

    The device maker says the technology can reduce the need for an additional assistant in the operating room, driving efficiency.

    By • Aug. 23, 2023
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    Medtronic
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    Medtronic raises earnings forecast amid supply chain, diabetes business improvements

    The company also shared an update on the planned divestment of its monitoring and respiratory interventions segments.

    By • Aug. 22, 2023
  • Birds-eye view of the Exonics headquarters building
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    Retrieved from Axonics on August 22, 2023
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    Axonics appoints Kari Keese to CFO post as Dan Dearen retires

    The retirement of company co-founder Dearen is “unexpected but not concerning,” Truist analyst Richard Newitter said.

    By • Aug. 22, 2023
  • Professional photo of Bryan Hanson
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    Courtesy of 3M
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    Zimmer Biomet CEO Hanson departs for 3M

    COO Ivan Tornos will become the orthopedic device maker’s new top executive.

    By • Aug. 22, 2023
  • Mergers and acquisitions
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    PeopleImages via Getty Images
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    Bruker to buy PhenomeX and its cell research tools for $108M

    The life science tools sector is ripe for consolidation, according to analysts at TD Cowen.

    By • Aug. 18, 2023
  • Nick Jonas poses in front of a glowing background, wearing a small, round device on his upper arm
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    Courtesy of Dexcom
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    Deep Dive

    Dexcom, Abbott ramp up DTC marketing amid fight for share of growing diabetes market

    As insurers cover continuous glucose monitors for more people, device-makers are taking a page from the pharma marketing playbook.

    By • Aug. 17, 2023
  • A surgeon holds a piece of surgical mesh for hernia and abdominal wall surgery.
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    Courtesy of Integra
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    Integra receives warning letter related to quality issues at Boston plant

    The company recalled all products made at its Boston facility over the last five years, and hopes to restart manufacturing in the fourth quarter.

    By • Updated Aug. 17, 2023
  • Philips, Trilogy, evo, respirator
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    Courtesy of Philips
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    One death, 2 injuries reported in recall of Philips Trilogy ventilators

    Philips warned in a previous recall about problems with the devices’ sensors that can lead to under-delivery of oxygen.

    By • Aug. 16, 2023
  • A patient wearing the GE HealthCare Portrait Mobile wireless monitoring device talks to a nurse while standing in a hospital hallway.
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    Retrieved from GE HealthCare via Business Wire.
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    GE HealthCare wins FDA clearance for wireless hospital vital sign monitor

    The Portrait Mobile device is one of GE HealthCare’s “first major introductions in monitoring in recent years,” according to the company.

    By • Aug. 16, 2023
  • Close up of a machine with several tubes, some of which are red.
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    saengsuriya13 via Getty Images
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    Medtronic’s dialysis device recall assigned to Class I by the FDA

    The company contacted customers after routine manufacturing testing identified a blockage that could obstruct the catheter.

    By • Aug. 16, 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 claims EOFlow copied patch-pump design in patent suit

    Insulet filed the lawsuit as competitor Medtronic plans to buy EOFlow for $738 million.

    By • Aug. 15, 2023
  • Judges Or Auctioneer Gavel On The Dollar Cash Background
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    Avosb via Getty Images
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    Medtronic’s bid to dismiss heart device kickback claims fails, clearing case to advance

    A whistleblower accused Medtronic of violating the False Claims Act by billing the government for unnecessary medical procedures.

    By • Updated Aug. 15, 2023
  • Aerial view of a sprawling Boston Scientific manufacturing plant
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    Courtesy of Boston Scientific
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    Boston Scientific’s pivotal pulsed field ablation trial expected to succeed: analysts

    Positive results could position Boston Scientific to win U.S. approval for Farapulse in the second half of next year.

    By • Aug. 14, 2023
  • A cylindrical device on the left with a wifi signal, next to a black rounded device and a smartphone showing a blood glucose reading.
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    Permission granted by Senseonics
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    Senseonics seeks iCGM designation for implantable glucose monitor

    The company also plans to submit results of a pivotal trial for a version of its device that can be worn for a year.

    By • Aug. 11, 2023
  • Medicare enrollment form and money.
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    iStock via Getty Images
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    Median lag between FDA authorization and Medicare coverage hits 6 years: study

    Fewer than 30% of novel medical devices obtain some Medicare coverage in the three years after regulatory authorization, researchers found.

    By • Aug. 11, 2023
  • The Getinge Cardiosave intra-aortic balloon pump system
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    Courtesy of Getinge
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    Getinge’s heart assist pump shutdown problem given FDA Class I recall tag

    The company notified healthcare providers after receiving 26 complaints about Cardiosave devices, used to support severely ill patients, unexpectedly shutting down.

    By • Aug. 11, 2023
  • A device with a loop on the end and a white balloon is in a blood vessel.
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    Permission granted by Boston Scientific
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    Boston Scientific receives FDA approval for cryoablation system

    The company hopes to build on interest in Europe and Japan as competitors bring new cardiac ablation devices to market.

    By • Aug. 10, 2023
  • A device with two metal plates and a white material in between.
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    Permission granted by ZimVie
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    ZimVie wins FDA approval for smaller Mobi-C cervical disc

    The device maker said the new product will “address the anatomical needs of the U.S. patient population.”

    By • Aug. 10, 2023
  • An operating room has a table surrounded by screens and several overhead lights, and a surgical robot that says "Mako"
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    Permission granted by Stryker
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    Stryker touts Mako robot in DTC ads, as device makers eye broader patient populations

    The company is taking its message on the benefits of robotic orthopedic surgery directly to patients at a time when analysts say medtech firms are targeting a wider audience through advertising.

    By • Aug. 9, 2023
  • An injection pen containing the drug semaglutide lies on a white plate.
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    Douglas Cliff via Getty Images
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    Device volumes to hold up against threat of Wegovy, other GLP-1 drugs: analysts

    Issues such as “nontrivial side effects, cost concerns and patient persistence” will mean physicians continue to use medical devices, analysts say.

    By • Aug. 9, 2023