Diagnostics


  • a lab worker with testubes of blood
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    Courtesy of GuardantHealth
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    FDA panel backs Guardant’s blood test for colon cancer

    “The favorable panel vote does not by any means imply this test will become an overnight success,” wrote William Blair analyst Andrew Brackmann.

    By May 24, 2024
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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
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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 lab technician runs Guardant Health's Shield blood test for colorectal cancer screening in a lab.
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    Courtesy of Business Wire
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    Guardant colon cancer test struggles to detect non-cancerous tumors, FDA says

    Agency scientists highlighted the risk in materials posted ahead of a Thursday advisory panel meeting for the Guardant Health blood test.

    By May 22, 2024
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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
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    Permission granted by Becton Dickinson
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    BD wins FDA approval for cervical cancer screening self-collection kit

    Patients can self-collect the samples in locations such as retail pharmacies, which could encourage more people to get tested.

    By May 17, 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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    FDA advises against using Cue Health COVID-19 tests, sends warning letter

    Agency inspectors found Cue made unauthorized changes to its COVID-19 kits that “reduced the reliability of the tests.”

    By May 14, 2024
  • A picture of Pacific Biosciences San Diego building.
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    Courtesy of Pacific Biosciences
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    Pacific Biosciences to lay off 195 employees as part of cost cuts

    More than half of the job losses stem from the closure of the genome sequencer’s San Diego office amid an ongoing industry slump.

    By May 14, 2024
  • Two ultrasound machines on wheels with screens showing medical images are side by side.
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    Courtesy of Samsung
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    Samsung Medison to buy AI ultrasound company Sonio

    Sonio’s software uses deep learning to improve image quality. Its software will remain compatible with all ultrasound machines, the company said.

    By May 8, 2024
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    Sarah Silbiger via Getty Images
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    Geneoscopy wins FDA approval for Labcorp-partnered colon cancer test

    Evercore and Cowen analysts expect Colosense to have a limited impact on Exact Sciences’ rival Cologuard test.

    By May 8, 2024
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    Nuthawut Somsuk via Getty Images
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    Karius raises $100M to expand access to multi-pathogen blood test

    Karius plans to use the funding to expand the test outside of the hospital setting and support research of the company’s DNA technology beyond infectious diseases.

    By May 6, 2024
  • Brian Blaser is smiling in a headshot with a blurred deep green background.
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    Courtesy of QuidelOrtho
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    QuidelOrtho names ex-Abbott exec Brian Blaser as CEO

    Blaser is coming out of retirement to take charge of QuidelOrtho, after the diagnostics company fired former CEO Doug Bryant in February.

    By May 3, 2024
  • A research scientist is at work in a laboratory setting.
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    sanjeri via Getty Images
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    Lab test overhaul: FDA to regulate LDTs as medical devices

    Stricter review of new tests developed by laboratories is coming, but some fear the changes will be expensive, time-consuming and discourage innovation.

    By May 3, 2024
  • Quest Diagnostics building
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    Courtesy of Quest Diagnostics
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    Quest to ramp up AI capabilities with purchase of PathAI’s diagnostic lab

    PathAI is selling its diagnostics assets, including a Tennessee laboratory, but will continue to support its biopharmaceutical customers.

    By May 2, 2024
  • 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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    Jon Cherry via Getty Images
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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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    deliormanli via Getty Images
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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
  • A picture of the exterior of a Labcorp building.
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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
  • Scientific illustration of a migrating breast cancer cell
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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