Diagnostics: Page 6
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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 -
Permission granted by Scopio Labs
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 Nick Paul Taylor • April 18, 2024 -
Nastassia Samal via Getty Images
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 Susan Kelly • April 18, 2024 -
Brad Barket via Getty Images
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 Elise Reuter • April 18, 2024 -
iStock/Getty Images Plus via Getty Images
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 Nick Paul Taylor • April 17, 2024 -
Courtesy of Abbott Laboratories
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 Elise Reuter • April 17, 2024 -
Courtesy of Exact Sciences
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 Elise Reuter • April 15, 2024 -
iStock via Getty Images
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 Nick Paul Taylor • April 15, 2024 -
Courtesy of Grail
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 Nick Paul Taylor • April 15, 2024 -
Courtesy of Roche
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 Susan Kelly • April 12, 2024 -
Courtesy of Illumina
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 Nick Paul Taylor • April 10, 2024 -
Courtesy of Exact Sciences
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 Nick Paul Taylor • April 9, 2024 -
Stock via Getty Images
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 Nick Paul Taylor • April 8, 2024 -
Dmitry Belyaev via Getty Images
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 Nick Paul Taylor • April 5, 2024 -
Courtesy of Beckman Coulter
Beckman Coulter receives FDA warning letter
Inspectors found fault with quality practices at a facility that makes immunoassay analyzer instruments and tests.
By Nick Paul Taylor • April 5, 2024 -
Permission granted by Eko Health
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 Nick Paul Taylor • April 4, 2024 -
Permission granted by QuidelOrtho
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 Susan Kelly • April 3, 2024 -
Permission granted by Abbott
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 Nick Paul Taylor • April 2, 2024 -
Courtesy of Exact Sciences
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 Elise Reuter • March 29, 2024 -
Courtesy of Labcorp
Labcorp inks $237.5M buyout of Opko’s reproductive, women’s health testing assets
The acquired assets generate about $100 million in annual revenue, according to the deal announcement.
By Nick Paul Taylor • March 29, 2024 -
Courtesy of Hologic
Hologic to lay off 190 workers as it closes European facilities
Three months after announcing unspecified international facility closures, Hologic has disclosed the number of affected employees and estimated $12.2 million in severance costs.
By Susan Kelly • Updated May 6, 2024 -
Courtesy of Roche
Roche wins FDA approval for first molecular malaria blood donor screening test
The company is pitching the test as a way to improve the safety and availability of blood.
By Nick Paul Taylor • March 28, 2024 -
Courtesy of Illumina
Court adviser sides with Illumina in EU row that triggered Grail fine
Illumina is still planning to divest Grail but may escape a fine of about 432 million euros imposed by the European Commission.
By Nick Paul Taylor • March 25, 2024
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