The Latest

  • Food And Drug Administration Headquarters In Maryland
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    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.

  • A person stands in front of the screen of a machine on wheels, near a sign that says "GE HealthCare"
    Image attribution tooltip
    Stringer via Getty Images
    Image attribution tooltip

    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.

  • The exterior of a U.S. Bankruptcy Courthouse.
    Image attribution tooltip
    GussWilder for iStock via Getty Images
    Image attribution tooltip

    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.

  • A person stands with a white, circular device attached to their upper arm.
    Image attribution tooltip
    Permission granted by Abbott
    Image attribution tooltip

    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.

  • Boston Scientific's Farapulse pulsed field ablation device.
    Image attribution tooltip
    Permission granted by Boston Scientific
    Image attribution tooltip

    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.

  • Two carts have mounted screens and surgical tools on them.
    Image attribution tooltip
    Courtesy of Johnson & Johnson
    Image attribution tooltip

    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.

  • A view of Baxter International's production facility in the state of North-Rhine Wetsphalia on January 15, 2021 in Halle, Germany.
    Image attribution tooltip
    Sascha Schuermann via Getty Images
    Image attribution tooltip

    CISA warns of cybersecurity risks in Baxter products

    The cybersecurity notices covered vulnerabilities identified in a Baxter Welch Allyn patient monitor and a Baxter Welch Allyn configuration tool.

    Updated June 10, 2024
  • A battery that says "AAA" on the left, is compared to two small, cylindrical devices on the right.
    Image attribution tooltip
    Courtesy of Abbott
    Image attribution tooltip

    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%.

  • A head shot of Martin Stumpe, Danaher's chief data and artificial intelligence officer.
    Image attribution tooltip
    Permission granted by Danaher
    Image attribution tooltip

    Danaher names Martin Stumpe as chief data and AI officer

    Martin Stumpe will take over the new position after previously working as Tempus’ chief of AI and the head of Google’s pathology team.

  • A building in front of a pond with the sign "Medtronic" on a stone wall.
    Image attribution tooltip
    Courtesy of Medtronic
    Image attribution tooltip

    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.

  • 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.

  • Prostate cancer cells, 3D illustration. Prostate cancer awareness image
    Image attribution tooltip
    Dr_Microbe via Getty Images
    Image attribution tooltip

    Saliva test identifies men at high risk of prostate cancer

    Data presented at the American Society of Clinical Oncology meeting suggest the test can support prostate cancer diagnosis in people who are missed by other screening methods.

  • Moon Surgical's Maestro robot is displayed in an operating room, accompanied by three clinicians.
    Image attribution tooltip
    Permission granted by Moon Surgical
    Image attribution tooltip

    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.

  • Professional photo of Marcus Schabacker in an office space.
    Image attribution tooltip
    Permission granted by ECRI
    Image attribution tooltip
    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.

  • A picture of two people sitting at a table looking at a smart phone.
    Image attribution tooltip
    Retrieved from Dexcom on June 05, 2024
    Image attribution tooltip

    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.

    Updated June 7, 2024
  • A Grail employee in a white coat works in a lab.
    Image attribution tooltip
    Courtesy of Grail
    Image attribution tooltip

    Illumina board approves Grail spinoff

    Leerink Partners analyst Puneet Souda said Grail, with a cash burn of $532 million in 2023, is likely to remain “a cautionary tale in diagnostics for years to come.”

    M&A
  • A close-up picture of an athlete holding her ankle in pain at the park.
    Image attribution tooltip
    skynesher via Getty Images
    Image attribution tooltip

    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.”

  • Professional photo of Everett Cunningham
    Image attribution tooltip
    Courtesy of Illumina
    Image attribution tooltip

    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.

  • Becton Dickinson logo
    Image attribution tooltip
    Permission granted by Becton Dickinson
    Image attribution tooltip

    BD to buy Edwards’ critical care unit for $4.2B

    Edwards will sell the business rather than pursue its original strategy announced in December to spin off the group.

    M&A
  • A person speaks in front of a screen showing four cards that read: Lingo Glucose, Lingo Ketone, Lingo Lactate and Lingo Alcohol
    Image attribution tooltip
    Ethan Miller via Getty Images
    Image attribution tooltip

    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.

  • m&a handshake
    Image attribution tooltip
    Natalie Meepian via Getty Images
    Image attribution tooltip

    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.

  • Steris image display in OR
    Image attribution tooltip
    Retrieved from Steris on June 20, 2023
    Image attribution tooltip

    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.

  • Wooden cubes that spell out "M&A"
    Image attribution tooltip
    Nastassia Samal via Getty Images
    Image attribution tooltip

    Surmodics agrees to $627M private equity buyout

    Surmodics will go private when the transaction closes, which is expected in the second half of the year.

    M&A
  • A child plays EndeavorRx on a tablet. The digital therapeutic intended to improve attention in kids with ADHD.
    Image attribution tooltip
    Permission granted by Akili Interactive
    Image attribution tooltip

    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.

  • A droplet from a pipette hangs over a series of test tubes in this stock image.
    Image attribution tooltip
    K-Kwanchai via Getty Images
    Image attribution tooltip

    Lab industry sues to stop FDA’s new LDT rule

    The American Clinical Laboratory Association argues the agency does not have the authority to enforce stricter standards on lab developed tests.