Diagnostics: Page 4
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Courtesy of Illumina
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.
By Nick Paul Taylor • June 4, 2024 -
K-Kwanchai via Getty Images
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.
By Susan Kelly • May 30, 2024 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical 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 -
Courtesy of GuardantHealth
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 Susan Kelly • May 24, 2024 -
Courtesy of Cue Health Press Kit
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 Elise Reuter • May 22, 2024 -
Courtesy of Business Wire
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 Susan Kelly • May 22, 2024 -
Carl Court via Getty Images
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 Nick Paul Taylor • May 22, 2024 -
Permission granted by Becton Dickinson
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 Nick Paul Taylor • May 17, 2024 -
Courtesy of Cue Health Press Kit
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 Nick Paul Taylor • May 14, 2024 -
Courtesy of Pacific Biosciences
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 Susan Kelly • May 14, 2024 -
Courtesy of Samsung
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 Elise Reuter • May 8, 2024 -
Sarah Silbiger via Getty Images
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 Nick Paul Taylor • May 8, 2024 -
Nuthawut Somsuk via Getty Images
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 Nick Paul Taylor • May 6, 2024 -
Courtesy of QuidelOrtho
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 Nick Paul Taylor • May 3, 2024 -
sanjeri via Getty Images
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 Susan Kelly • May 3, 2024 -
Courtesy of Quest Diagnostics
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 Nick Paul Taylor • May 2, 2024 -
Jon Cherry via Getty Images
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 Susan Kelly • April 30, 2024 -
Justin Sullivan via Getty Images
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 Nick Paul Taylor • April 30, 2024 -
deliormanli via Getty Images
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 Susan Kelly • April 29, 2024 -
Courtesy of Labcorp
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 Susan Kelly • April 25, 2024 -
AnkiHoglund via Getty Images
Medtech’s top executive moves in 2024
Recent executive changes include former Medtronic CFO Karen Parkhill leaving for HP and Masimo CEO Joe Kiani resigning. Check out MedTech Dive’s roundup of leadership movement in 2024.
By Susan Kelly , Ricky Zipp • Updated Sept. 26, 2024 -
solarseven via Getty Images
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 Susan Kelly • April 25, 2024 -
Courtesy of Elekta
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 Elise Reuter • April 23, 2024 -
Stock via Getty Images
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 Nick Paul Taylor • April 22, 2024 -
LordHenriVoton, E+ via Getty Images
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 Susan Kelly • April 19, 2024 -
Sascha Schuermann via Getty Images
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 Nick Paul Taylor • April 19, 2024
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