Medical Devices: Page 12


  • 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
  • Front sign of FDA building Explore the Trendline
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    Sarah Silbiger via Getty Images
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    Trendline

    Medical device safety in spotlight after high profile recalls

    From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

    By MedTech Dive staff
  • 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
  • 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
  • A headshot of Medtronic's Linnea Burman.
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    Permission granted by Medtronic
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    Medtronic elevates Linnea Burman to president of neurovascular unit

    Burman will oversee strategy, product development and financial performance for a unit focused on stroke care.

    By May 29, 2024
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    Patrik Stollarz / Staff via Getty Images
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    Philips reports 7 deaths linked with BiPAP alarm problem

    Philips recalled three BiPAP models because an alarm can incorrectly engage and shut down the ventilator under certain circumstances. 

    By May 29, 2024
  • Sanket Shah stands in front of a wood wall.
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    Permission granted by Otsuka Precision Health
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    Otsuka defies digital health downturn with new company

    With “no playbook out there” to fall back on, the new company is taking a long-term approach as it develops its portfolio, an Otsuka Precision Health exec told MedTech Dive.

    By May 29, 2024
  • A blue, wavy device resembles a thin sponge.
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    Permission granted by Johnson & Johnson
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    Q&A

    J&J’s Nisha Johnson on Ethizia wound-sealing patch, biosurgery market

    With the recent launch of the hemostatic healing patch in Europe, J&J expects to lead the biosurgery and wound closure market. 

    By May 28, 2024
  • Intuitive Surgical's da Vinci 5 robotic system.
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    Courtesy of Intuitive Surgical
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    New products take center stage in medtech’s latest earnings season

    From pulsed field ablation devices to Intuitive's latest da Vinci robot, product launches dominated recent earnings calls.

    By May 28, 2024
  • A union jack flag waves in the wind
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    Ramberg via Getty Images
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    UK regulator proposes recognizing overseas medical device approvals

    Companies with authorization in certain regions, including the EU and U.S., would be able to use their approvals to access Great Britain’s market.

    By May 24, 2024
  • An image of Medtronics PulseSelect pulsed field ablation system
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    Courtesy of Medtronic
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    Medtronic touts demand for PFA, adding to hype for the new ablation tech

    CEO Geoff Martha told investors there has already been “strong adoption” of PFA devices and the category will be a big part of Medtronic's revenue growth in fiscal year 2025.

    By May 23, 2024
  • A person holds a clear, spiral shaped device with metal dots.
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    Retrieved from Hologic on May 23, 2024
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    Hologic recalls more than 53,000 radiographic markers linked to 71 injuries

    The Biozorb devices are staying on the market, but Hologic has asked people to report adverse events such as pain.

    By May 23, 2024
  • Promotional courtesy shot of a Cue Health Covid-19 test
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    Courtesy of Cue Health Press Kit
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    Cue Health to lay off remaining employees, shut down

    Once a COVID-testing darling, Cue will close after raising hundreds of millions of dollars and striking high-profile partnerships with Google and the NBA during the pandemic.

    By May 22, 2024
  • A person smiles while wearing a square device on their hip and a round device on their upper arm.
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    Courtesy of Tandem Diabetes Care
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    Medicare adviser sets recommendations for diabetes device evidence

     A MEDCAC panel found time in range was an “extremely important” metric, but members were divided on whether quality of life measures should influence coverage.

    By May 22, 2024
  • European Union flags are pictured outside the European Commission building.
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    Carl Court via Getty Images
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    EMA updates advice on drug-device combinations under MDR, IVDR

    The European Medicines Agency answered six new questions to clarify topics such as how companies can get advice on borderline products.

    By May 22, 2024