Diagnostics

  • The exterior of the Veterans Affairs Hospital in New York City.
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    Spencer Platt/Getty Images via Getty Images
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    Medtronic wins VA contract to install AI-powered endoscopy units

    The three-year contract expands Medtronic’s work with the VA to cover the installation of almost 100 more GI Genius endoscopy modules at U.S. medical centers.

    By • Nov. 26, 2024
  • A headshot of Julia Wang, Labcorp's incoming CFO.
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    Permission granted by Labcorp
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    Labcorp hires Julia Wang as CFO

    Wang will replace Glenn Eisenberg, who is retiring after 10 years in the role. Evercore analysts called Eisenberg a Labcorp “institution.”

    By • Nov. 20, 2024
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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 person head is shown inside GE Healthcare's Signa Magnus MRI machine.
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    Retrieved from GE Healthcare on November 14, 2024
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    GE Healthcare’s head-only MRI scanner cleared by the FDA

    The system is designed to shorten scan times, which may be better for people who struggle to stay still or have claustrophobia, and to detect more subtle abnormalities.

    By • Nov. 14, 2024
  • Anne Wojcicki sits in a chair speaking with Marcus Wallenberg during an event.
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    Kimberly White/Getty Images via Getty Images
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    23andMe to lay off more than 200 employees amid business struggles

    The genetic testing firm will also close its therapeutics arm. CEO Anne Wojcicki said the cuts are necessary to “focus on the long-term success of our core consumer business.”

    By • Nov. 13, 2024
  • Republican Presidential Nominee Donald Trump Holds Election Night Event In West Palm Beach
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    Win McNamee/Getty Images via Getty Images
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    Advamed CEO congratulates Trump, stresses need for public policy support

    Donald Trump’s election victory comes weeks after the FDA named a new leader for the medical device center and as the agency’s contentious LDT final rule is challenged in court.

    By • Nov. 11, 2024
  • A person wearing goggles and holding a clipboard looks at a tray in a laboratory.
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    Courtesy of Exact Sciences
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    Exact Sciences’ forecast cut shocks analysts

    The lowered sales forecast, which analysts called a “shocking guidance update,” contributed to a 23% drop in the cancer screening company’s stock on Wednesday.

    By • Nov. 8, 2024
  • Close up of a robotic arm above several lines of test tubes, with people looking in through a glass window.
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    Courtesy of Ambry Genetics
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    Tempus AI to buy genetic testing company for $600M

    CEO Eric Lefkofsky said the purchase of Ambry Genetics will expand Tempus’ testing portfolio and bring in a fast-growing business.

    By • Nov. 6, 2024
  • A person in scrubs and gloves holds an image of a mammogram above a lighted panel
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    Thomas Andreas via Getty Images
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    Advamed asks CMS to cover extra imaging of dense breast tissue

    Many patients with dense breast tissue currently have to pay out of pocket or forgo potentially life-saving additional testing, Advamed said in a letter.

    By • Nov. 6, 2024
  • European Union flags are pictured waving outside the European Commission building.
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    Carl Court via Getty Images
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    European Parliament calls for proposals to reform MDR and IVDR by end of Q1

    Parliament asked the European Commission to publish acts that address the “most pressing challenges and bottlenecks” of the regulations and propose the “systematic revision” of the legislation.

    By • Oct. 24, 2024
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    Elise Reuter/MedTech Dive
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    The Medtech Conference

    Medtech Conference recap: New CDRH leader details approach; AI and LDTs in focus

    Catch up on our recent coverage of Advamed’s The Medtech Conference.

    By • Oct. 23, 2024
  • Two scans of a shoulder side by side. The image on the right is sharper.
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    Permission granted by GE Healthcare
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    GE Healthcare opens AI Innovation Lab to grow new projects

    The AI Innovation Lab is designed to accelerate early concept artificial intelligence projects including tools to predict the recurrence of cancer and automate image interpretation.

    By • Oct. 22, 2024
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    Flickr; The U.S. Food and Drug Administration
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    Deep Dive

    5 steps to navigate the FDA’s new lab developed test rule

    Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five strategies labs can take to be ready.

    By • Oct. 21, 2024
  • Front sign of FDA building
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    Sarah Silbiger via Getty Images
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    FDA prioritizes guidance on lab developed tests in 2025 plan

    The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs, among other topics.

    By • Oct. 18, 2024
  • EU flags in front of the Berlaymont building, headquarters of the European Commission in Brussels, Belgium.
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    Alxpin via Getty Images
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    Medtech Europe calls for urgent reform of MDR and IVDR

    The trade group’s intervention follows news that the new commissioner for Health and Animal Welfare will assess the need for legislative changes.

    By • Oct. 18, 2024
  • A rounded, glass building that says "Metro Toronto Convention Centre" at dusk in front of the Toronto skyline.
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    Courtesy of Metro Toronto Convention Centre
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    The Medtech Conference

    4 trends to watch at Advamed’s The Medtech Conference

    As medtech companies, experts and regulators gather in Toronto, FDA leadership changes and the upcoming U.S. presidential election loom over the industry.

    By • Oct. 14, 2024
  • A person wearing goggles and holding a clipboard looks at a tray in a laboratory.
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    Courtesy of Exact Sciences
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    Exact Sciences wins FDA approval for Cologuard Plus colorectal cancer test

    Exact Sciences expects to launch the updated test, which has higher specificity than its predecessor, with Medicare coverage and guideline inclusion in 2025.

    By • Oct. 7, 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 gets FDA nod for new PET imaging agent

    Called Flyrcado, the radiotracer could help improve cardiac imaging accuracy in patients with a high body mass index and women, the company said.

    By • Oct. 1, 2024
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    halbergman via Getty Images
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    Top medtech conferences in 2025

    The lineup includes industrywide conferences and events covering the latest medtech trends in diabetes, orthopedics, cardiac care and surgical robotics.

    By • Oct. 1, 2024
  • The sun sets behind the US Capitol
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    Tom Brenner via Getty Images
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    Congress again delays steep cuts in Medicare lab payments

    The American Clinical Laboratory Association welcomed the reprieve but said long-term reform of the Medicare payment system is still needed.

    By • Sept. 26, 2024
  • A sign for the FDA is displayed outside the agency's headquarters in Silver Spring, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA proposes reclassifying hepatitis B assays

    The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.

    By • Sept. 26, 2024
  • A Roche logo is seen on the side of a building.
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    Courtesy of Roche
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    Roche launches test that detects 12 respiratory viruses

    Roche’s TAGS technology allows tests to simultaneously detect multiple respiratory viruses, including influenza A and B, RSV and the COVID-19 virus.

    By • Sept. 25, 2024
  • A physician looks at computer screens that show brain imaging.
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    Courtesy of GE Healthcare
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    GE Healthcare wins FDA clearance for Alzheimer’s imaging software

    The clearance adds a Centiloid scale tool to GE Healthcare’s Mim software to help clinicians determine the density of amyloid plaque.

    By • Sept. 20, 2024
  • Anne Wojcicki sits in a chair speaking with Marcus Wallenberg during an event.
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    Kimberly White/Getty Images via Getty Images
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    23andMe’s independent board directors resign

    In a letter to CEO Anne Wojcicki, the directors said they’d resign “rather than have a protracted and distracting difference of view with you” about the company’s future.

    By • Sept. 19, 2024
  • Senior Research Associate Tanya Quint loads one of the instruments used to run Exact Sciences' Cologuard test at the company's headquarters in Madison, Wis. (Photo: Business Wire)
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    Courtesy of Business Wire/Exact Sciences
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    Exact Sciences says data support its colon cancer blood test

    Exact’s test could compete with Guardant Health’s Shield blood test, which received approval from the Food and Drug Administration in July.

    By • Sept. 16, 2024
  • An image of Inflammatix's TriVerity Acute Infection and Sepsis Test.
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    Courtesy of Inflammatix
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    Inflammatix raises $57M to advance test for infection, sepsis

    Inflammatix has now raised over $200 million in private capital, in addition to more than $50 million in grants and contracts.

    By • Sept. 13, 2024