Diagnostics

  • A picture of the exterior of a Labcorp building.
    Image attribution tooltip
    Courtesy of Labcorp
    Image attribution tooltip

    Labcorp to acquire Invitae’s assets for $239M

    William Blair analyst Andrew Brackmann said Labcorp is being aggressive in its M&A strategy, after announcing last month it would buy several of Bioreference Health’s testing businesses.

    By • April 25, 2024
  • Close up of feet walking through a revolving door.
    Image attribution tooltip
    AnkiHoglund via Getty Images
    Image attribution tooltip

    Medtech’s top executive moves in 2024

    Philips, Illumina, Insulet and Exact Sciences have all gained new CFOs in recent weeks.

    By • April 25, 2024
  • Close up of hand touching smartwatch with health app on the screen. Explore the Trendline➔
    Image attribution tooltip
    Sitthiphong via Getty Images
    Image attribution tooltip
    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
  • Blood samples and test results in a clinical medical laboratory.
    Image attribution tooltip
    solarseven via Getty Images
    Image attribution tooltip

    Freenome to cut more than 100 employees in restructuring

    Intended to preserve resources, the layoffs come weeks after Freenome released study data on its blood test for colorectal cancer that fell short of competitors’ results. 

    By • April 25, 2024
  • A person lays in front of a radiation therapy machine with both arms up while another person assists them.
    Image attribution tooltip
    Courtesy of Elekta
    Image attribution tooltip

    GE Healthcare subsidiary expands radiation therapy partnership with Elekta

    MIM Software, which GE Healthcare acquired earlier this month, will work with Elekta to improve treatment planning and workflows.

    By • April 23, 2024
  • Scientific illustration of a migrating breast cancer cell
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    FDA approves Lumicell’s breast cancer imaging tool

    Lumicell developed the technology to enable physicians to detect residual cancer in the breast cavity after surgery.

    By • April 22, 2024
  • A picture of dermatologist examining patient skin moles with a dermoscope at a health clinic.
    Image attribution tooltip
    LordHenriVoton, E+ via Getty Images
    Image attribution tooltip

    Cancer test maker Dermtech to cut 100 jobs, explore strategic options

    Dermtech, which will not hold a first-quarter earnings call, said the layoffs are part of a broader effort to “significantly reduce” expenses.

    By • April 19, 2024
  • 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

    Spinoffs, sales and tuck-ins top medtech deal priorities: Moody’s

    After J&J’s $13.1 billion purchase of Shockwave Medical, Moody’s analysts see the potential for other larger pick-ups “if interest rates substantially decrease.”

    By • April 19, 2024
  • A picture of a computer screen with Scopio Labs' bone marrow analysis software on it.
    Image attribution tooltip
    Permission granted by Scopio Labs
    Image attribution tooltip

    Scopio Labs wins de novo nod for bone marrow analysis software

    Scopio can now add the application to its imaging platforms that allow users to view blood samples digitally rather than under a microscope.

    By • April 18, 2024
  • Blocks spell M and A
    Image attribution tooltip
    Nastassia Samal via Getty Images
    Image attribution tooltip

    Bruker to acquire Nanostring for $393M

    Bruker made an offer roughly two months after Nanostring filed for bankruptcy protection and said it may restructure.

    By • April 18, 2024
  • Anne Wojcicki speaking event
    Image attribution tooltip
    Brad Barket via Getty Images
    Image attribution tooltip

    23andMe CEO plans to take company private

    Anne Wojcicki wants to buy all outstanding shares of the DNA testing firm, which has seen its stock slump in recent years.

    By • April 18, 2024
  • Rendering of digital data code in safety security technology concept.
    Image attribution tooltip
    iStock/Getty Images Plus via Getty Images
    Image attribution tooltip

    Files taken from Orasure systems in cybersecurity incident

    Orasure believes it has contained the incident and “preserved the integrity of its core financial and operational systems.”

    By • April 17, 2024
  • Abbott company sign outside
    Image attribution tooltip

    Courtesy of Abbott Laboratories

    Image attribution tooltip

    Abbott looks to ‘highly productive’ device pipeline for future growth

    CEO Robert Ford highlighted new and upcoming products throughout the earnings call, calling the recently approved Triclip valve a “billion-dollar opportunity."

    By • April 17, 2024
  • Exact Sciences precision oncology lab
    Image attribution tooltip
    Courtesy of Exact Sciences
    Image attribution tooltip

    Exact Sciences names Aaron Bloomer CFO

    The executive will succeed Jeff Elliott, who said in January he would step down due to personal reasons.

    By • April 15, 2024
  • Roche Pharmaceutical Group's office building in Shanghai, China
    Image attribution tooltip
    iStock via Getty Images
    Image attribution tooltip

    Roche to distribute Prenosis’ AI sepsis detection tool in US

    Roche will make the tool available as part of its Navify Algorithm Suite, a collection of medical algorithms the company has validated.

    By • April 15, 2024
  • A person wearing safety goggles holds a pipette of fluid.
    Image attribution tooltip
    Courtesy of Grail
    Image attribution tooltip

    European Commission approves Illumina’s proposed Grail split

    Selling Grail to a third party would free Illumina of the need to capitalize the company, but the buyer would need the commission’s approval, analysts wrote.

    By • April 15, 2024
  • Roche's Cobas Pro system for laboratories.
    Image attribution tooltip
    Courtesy of Roche
    Image attribution tooltip

    Roche scores FDA breakthrough status for Alzheimer’s blood test

    The plasma assay is intended to aid in finding amyloid pathology, a biomarker of Alzheimer’s disease.

    By • April 12, 2024
  • A headshot of Illumina's former CFO Joydeep Goswami
    Image attribution tooltip
    Courtesy of Illumina
    Image attribution tooltip

    Illumina CFO steps down amid executive shakeup

    Ankur Dhingra, who worked with Illumina’s CEO at Agilent Technologies, is joining the genome sequencing company to replace Joydeep Goswami.

    By • April 10, 2024
  • A person wearing goggles and holding a clipboard looks at a tray in a laboratory.
    Image attribution tooltip
    Courtesy of Exact Sciences
    Image attribution tooltip

    Exact Sciences’ cancer blood test achieves 51% sensitivity in prospective trial

    Sensitivity for the multi-cancer early detection test rose to almost 64% in the six cancers with the shortest five-year survival rate.

    By • April 9, 2024
  • dna tube
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip

    Physicians ask FDA to revoke approval of DNA test for opioid addiction

    Physicians said the test is based “on old genetic studies that have largely been abandoned” and could exacerbate the opioid crisis.

    By • April 8, 2024
  • A person wearing a blue glove holds a test tube with red liquid
    Image attribution tooltip
    Dmitry Belyaev via Getty Images
    Image attribution tooltip

    Freenome’s colorectal cancer blood test data underwhelm analysts

    Cowen analysts said Freenome’s results are good news for competitors Exact Sciences and Guardant Health.

    By • April 5, 2024
  • A large machine on a wheels with an attached screen.
    Image attribution tooltip
    Courtesy of Beckman Coulter
    Image attribution tooltip

    Beckman Coulter receives FDA warning letter

    Inspectors found fault with quality practices at a facility that makes immunoassay analyzer instruments and tests.

    By • April 5, 2024
  • A picture of Eko Health's stethoscope AI system.
    Image attribution tooltip
    Permission granted by Eko Health
    Image attribution tooltip

    Eko wins FDA nod for AI to detect sign of heart failure using stethoscope

    The clearance adds to the list of devices the FDA has authorized this year with AI algorithms to detect health conditions.

    By • April 4, 2024
  • Professional photo of Michael Iskra
    Image attribution tooltip
    Permission granted by QuidelOrtho
    Image attribution tooltip

    QuidelOrtho pulls FDA submission of 4-virus test

    The diagnostics company said it is developing a next-generation combination respiratory assay after data for the initial test did not meet its expectations.

    By • April 3, 2024
  • A blue and white reader next to a cartridge that says i-STAT TBI.
    Image attribution tooltip
    Permission granted by Abbott
    Image attribution tooltip

    Abbott wins FDA clearance for bedside blood concussion test

    The clearance is a step towards using the test in non-healthcare settings, such as sporting events, Abbott said.

    By • April 2, 2024
  • A person wearing goggles and holding a clipboard looks at a tray in a laboratory.
    Image attribution tooltip
    Courtesy of Exact Sciences
    Image attribution tooltip

    Exact Sciences, Mayo Clinic share early data on esophageal cancer test

    Designed as an alternative to endoscopy, the cancer screening test uses a sponge collection device that's paired with an algorithm.

    By • March 29, 2024