Diagnostics

  • Deira Ward (L) and Lisa Bates (R) work at a computer near a large PCR analysis machine at a Quest Diagnostics testing lab in Indianapolis, Indiana. The lab is capable of processing up to 3700 tests pe
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    FDA defends LDT final rule, while critics fear it upends lab industry

    The new policy aims to ensure important diagnostics remain available to patients, but some experts caution the increased regulatory burdens could slow access to testing.

    By • April 30, 2024
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    Justin Sullivan via Getty Images
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    Labcorp gains FDA approval for companion diagnostic to Pfizer gene therapy

    The test would determine if patients are eligible for Pfizer’s new hemophilia B treatment by detecting if they have been exposed to a virus that could make the gene therapy less effective.

    By • April 30, 2024
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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
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    FDA finalizes lab developed test rule despite industry opposition

    Risks associated with the tests have increased, requiring greater oversight to protect patients, the agency contends.

    By • April 29, 2024
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    Courtesy of Labcorp
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    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
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    AnkiHoglund via Getty Images
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    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
  • Blood samples and test results in a clinical medical laboratory.
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    solarseven via Getty Images
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    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.
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    Courtesy of Elekta
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    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
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    Stock via Getty Images
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    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.
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    LordHenriVoton, E+ via Getty Images
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    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.
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    Sascha Schuermann via Getty Images
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    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.
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    Permission granted by Scopio Labs
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    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
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    Nastassia Samal via Getty Images
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    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
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    Brad Barket via Getty Images
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    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
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    iStock/Getty Images Plus via Getty Images
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    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
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    Courtesy of Abbott Laboratories

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    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
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    Courtesy of Exact Sciences
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    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
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    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
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    Courtesy of Grail
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    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.
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    Courtesy of Roche
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    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
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    Courtesy of Illumina
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    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.
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    Courtesy of Exact Sciences
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    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
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    Stock via Getty Images
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    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
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    Dmitry Belyaev via Getty Images
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    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
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    Courtesy of Beckman Coulter
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    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.
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    Permission granted by Eko Health
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    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