Medical Devices: Page 22


  • the FDA Headquarters
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    Sara Silbiger via Getty Images
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    Medline pulls thousands of endotracheal tubes due to risk of airway blockage

    Medline asked hospitals to immediately identify and destroy any affected devices.

    By June 13, 2024
  • An American flag waves in front of the Department of Justice exterior. It is a neo-classical building with columns.
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    Kevin Dietsch / Staff via Getty Images
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    Masimo embroiled in dual DOJ, SEC probes

    Masimo will have to juggle the government inquiries while also dealing with an activist investor-led proxy battle.

    By June 13, 2024
  • Close up of hand touching smartwatch with health app on the screen. Explore the Trendline
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    Sitthiphong via Getty Images
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
  • A picture of Philips' Duo Venous Stent System against a white background.
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    Courtesy of Philips
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    Philips launches stent system to restore blood flow in blocked veins

    Philips acquired the device as part of its 227 million euro purchase of Vesper Medical in 2022.

    By June 13, 2024
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    Fotolia
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    Kardium raises $104M to develop pulsed field ablation system

    Kardium will use the funding to complete a clinical study for pursuing regulatory approvals and build its manufacturing, clinical support and commercial teams.

    By June 12, 2024
  • A female doctor and senior patient discuss medical records.
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    SDI Productions via Getty Images
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    Women underrepresented in trials of high-risk medical implants: study

    A median of 33% of study subjects were women, and the figure was significantly lower in cardiovascular trials.

    By June 12, 2024
  • A doctor checks the knee of a patient seated on an examination table.
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    PeopleImages via Getty Images
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    Zimmer partners with Think Surgical to launch knee surgery robot

    J.P. Morgan analysts said the move is a “low cost way of adding more robotic options” for Zimmer, but they were still unsure about the added value of the partnership.

    By June 12, 2024
  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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    Abbott issues recall for Heartmate system monitor

    Abbott’s heart pump system and related products have been part of multiple Class I recalls this year.

    By June 11, 2024
  • The exterior of a U.S. Bankruptcy Courthouse.
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    GussWilder for iStock via Getty Images
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    Vyaire Medical files for Chapter 11 bankruptcy

    CEO John Bibb said the move gives Vyaire “breathing room” as the ventilator manufacturer looks to sell its businesses.

    By June 11, 2024
  • A person stands in front of the screen of a machine on wheels, near a sign that says "GE HealthCare"
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    Stringer via Getty Images
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    GE Healthcare names new leaders of imaging and ultrasound units

    Roland Rott will become CEO of GE Healthcare’s imaging business, while Philip Rackliffe will lead a combined ultrasound and image guided therapies segment.

    By June 11, 2024
  • A person stands with a white, circular device attached to their upper arm.
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    Permission granted by Abbott
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    Abbott ramps up over-the-counter CGM race with new sensors

    Abbott will launch two over-the-counter glucose monitors in the U.S., competing directly with Dexcom’s Stelo.

    By June 10, 2024
  • Two carts have mounted screens and surgical tools on them.
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    Courtesy of Johnson & Johnson
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    J&J wins expanded FDA clearance for knee surgery robot

    Johnson & Johnson has identified Velys as a product that can help it regain market share from rivals such as Stryker.

    By June 10, 2024
  • Boston Scientific's Farapulse pulsed field ablation device.
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    Permission granted by Boston Scientific
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    Pulsed field ablation to ‘cannibalize’ radiofrequency, cryo: Needham

    Boston Scientific is forecast to gain the largest share of the U.S. ablation catheter market in the next 12 months, at the expense of Abbott and J&J.

    By June 10, 2024
  • 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 wins CE mark for dual-chamber leadless pacemaker

    Abbott sees the device as a product that can help its rhythm management business grow 6% to 7%.

    By June 7, 2024
  • A building in front of a pond with the sign "Medtronic" on a stone wall.
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    Courtesy of Medtronic
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    Medtronic recalls neurosurgery navigation system for software error

    A problem with the Stealthstation S8 could cause incorrect device placement during surgery. It is the fourth recall of Stealthstation software in the past 12 months.

    By June 6, 2024
  • A closeup of Edwards Lifesciences' Sapien 3 heart valve.
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    Courtesy of Edwards Lifesciences
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    Sapien valve performs equally well for small and large aortic annuli, Edwards finds

    The analysis adds to a debate about the effectiveness of Edwards versus Medtronic TAVR devices in patients with small aortic annuli, a fibrous ring around the heart’s valve.

    By June 6, 2024
  • Moon Surgical's Maestro robot is displayed in an operating room, accompanied by three clinicians.
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    Permission granted by Moon Surgical
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    Moon Surgical secures FDA nod for commercial soft tissue robot

    Moon joins an expanding list of robot makers aiming to compete in a soft tissue surgery market led by Intuitive Surgical.

    By June 5, 2024
  • Professional photo of Marcus Schabacker in an office space.
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    Permission granted by ECRI
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    Q&A

    Stronger oversight of AI needed in medical devices, ECRI CEO says

    Marcus Schabacker called for more upfront regulations and postmarket monitoring to better understand how AI features affect patient care.

    By June 5, 2024
  • A picture of two people sitting at a table looking at a smart phone.
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    Retrieved from Dexcom on June 05, 2024
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    Dexcom connects G7 CGM directly to Apple Watch in US

    Apple Watch and G7 users can now view real-time glucose readings on their wrist, regardless of whether they are carrying an iPhone.

    By Updated June 7, 2024
  • Professional photo of Everett Cunningham
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    Courtesy of Illumina
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    Illumina names Everett Cunningham as chief commercial officer

    Cunningham will join Illumina from Exact Sciences to end the six-month search for a permanent leader.

    By June 4, 2024
  • A close-up picture of an athlete holding her ankle in pain at the park.
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    skynesher via Getty Images
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    Stryker inks Artelon buyout to join Zimmer in soft tissue space

    BTIG analysts said the takeover could serve as a "defensive mechanism against peers who have been growing rapidly in the space.”

    By June 4, 2024
  • 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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    Abbott receives FDA OK for over-the-counter glucose monitor

    After debuting its Lingo device in the U.K. last year, Abbott can now sell the sensor in the U.S.

    By June 3, 2024
  • m&a handshake
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    Natalie Meepian via Getty Images
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    Medtech venture capital investing rebounded in Q1

    Pitchbook analysts are cautiously optimistic that the funding pickup will continue despite uncertainty about interest rates, heightened regulatory scrutiny and the presidential election.

    By June 3, 2024
  • Steris image display in OR
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    Retrieved from Steris on June 20, 2023
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    Steris to lay off employees in restructuring

    Steris said it would cut “less than 300 positions” as it consolidates facilities, continuing the trend of medtechs laying off employees to save costs or reorganize businesses.

    By May 31, 2024
  • A child plays EndeavorRx on a tablet. The digital therapeutic intended to improve attention in kids with ADHD.
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    Permission granted by Akili Interactive
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    Digital therapeutics firm Akili to sell for $34M

    Akili, which makes a video game treatment for ADHD, will merge with Virtual Therapeutics to create a larger digital health entity.

    By May 30, 2024
  • Fresenius' corporate headquarters in Bad Homburg, Germany.
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    Courtesy of Fresenius
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    Fresenius Medical Care plans layoffs ahead of California plant closure

    More than 300 people will be affected as the company shifts dialysis manufacturing to a facility in Mexico.

    By May 30, 2024