Diagnostics: Page
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Neilson Barnard via Getty Images
Illumina urges shareholders to reject Icahn board nominees
The DNA-sequencing company says Icahn’s board nominees don’t understand its business or the regulatory process.
By Susan Kelly • March 31, 2023 -
Courtesy of Elypta
Potential to improve early cancer detection lands Elypta prize inspired by Star Trek creator
The metabolism-based liquid biopsy improved on the ability of genomic tests to detect stage I cancers in a recent study.
By Nick Paul Taylor • March 30, 2023 -
Explore the Trendline➔
Sarah Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Ewa Krawczyk, National Cancer Institute
Breast cancer AI company iCAD lays off workers, names new CEO
The company, which reported a net loss on Tuesday, is also exploring strategic alternatives for its Xoft therapy business.
By Susan Kelly • March 29, 2023 -
Courtesy of Qiagen
Qiagen’s Thierry Bernard named chair of the AdvaMedDx board
Thierry Bernard, the CEO of Qiagen, succeeds Norman Schwartz, CEO of Bio-Rad Laboratories, in leading the diagnostics division of trade association AdvaMed.
By Susan Kelly • March 28, 2023 -
Courtesy of Antennaware
AntennaWare secures patent for wireless tech designed to unlock implant applications
AntennaWare sees the technology facilitating deep-tissue implants that unlock new ways to monitor and treat disease.
By Nick Paul Taylor • March 27, 2023 -
Mat Szwajikos via Getty Images
Icahn says Illumina directors got personal insurance after Grail deal
The extra liability coverage shows the directors feared unspecified consequences from closing the acquisition of Grail, according to the activist investor.
By Susan Kelly • Updated March 24, 2023 -
Roche, Lilly team on test for early detection of Alzheimer’s
The tool is intended to help gauge whether patients should receive further evaluation to confirm a diagnosis.
By Susan Kelly • Updated March 22, 2023 -
Courtesy of Grail
Illumina, facing Icahn challenge, ‘moving quickly’ on resolution for Grail
The DNA-sequencing company said the activist investor hasn’t offered any better solutions for satisfying regulators’ concerns about the acquisition.
By Susan Kelly • March 20, 2023 -
Sarah Silbiger via Getty Images
FDA sets end date for raft of COVID-related shortages that began early in pandemic
Shortages of home-use ventilators and clinical sample concentrators are expected to continue.
By Nick Paul Taylor • March 20, 2023 -
Getty Images
Medtech trade group pushes UK to support ambitious Software as a Medical Device program
Reams of data collected by the National Health Service, paired with advanced work in artificial intelligence at U.K. universities, could make Britain a digital health leader if the government acts.
By Nick Paul Taylor • March 15, 2023 -
Courtesy of QuidelOrtho
QuidelOrtho COVID test is first to win FDA nod via premarket review
Special controls instituted by the FDA as part of the De Novo assessment pave the way for other tests to come to market without pandemic-era Emergency Use Authorization.
By Nick Paul Taylor • March 9, 2023 -
Abbott gets FDA nod on lab blood test for concussion
Results are available in about 18 minutes and can rule out the need for a CT scan if negative, the company said.
By Susan Kelly • March 8, 2023 -
Permission granted by iRhythm Technologies
iRhythm, fighting Boston Scientific for market share, shows cardiac monitor beats rivals
An analysis of Medicare claims data found iRhythm Technologies’ Zio XT outperforms other ambulatory cardiac monitors.
By Nick Paul Taylor • March 8, 2023 -
Paula Bronstein via Getty Images
Phone app tracks cough frequency in tuberculosis trial, opening up monitoring opportunity
If validated in further studies, the work could further expand the use of smartphones as diagnostic tools, particularly in areas where there are few medical professionals, and could help stop overtreatment of TB.
By Nick Paul Taylor • March 6, 2023 -
Sarah Silbiger/Getty Images via Getty Images
FDA moving ahead with rulemaking on lab developed tests without waiting for Congress: BioWorld
A senior FDA official said the agency cannot “just stand by” given the failure of Congress to pass legislation addressing regulation of the increasingly complex tests.
By Nick Paul Taylor • March 2, 2023 -
Getty Images
Remote patient monitoring increasingly popular, even as pandemic eases, analysis of insurance claims shows
Cardiologists are the main users of RPM devices, with blood pressure diagnoses accounting for more than half of all claims made in 2021. Diabetes, which accounts for 16% of claims, is the next most active area.
By Nick Paul Taylor • March 2, 2023 -
Megan Quinn/MedTech Dive
AdvaMed unveils policy priorities with focus on breakthrough device coverage, global market access
Congress should also prioritize protecting the medtech manufacturing supply chain and enact diagnostic testing reform, the lobbying group said in releasing a set of nine policy goals.
By Susan Kelly • March 1, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA authorizes first at-home flu-COVID-19 combination test days after its developer files for bankruptcy
Lucira filed for bankruptcy protection last week, saying the “protracted” authorization process caused it to miss out on test sales in the 2022 to 2023 flu season.
By Nick Paul Taylor • Feb. 27, 2023 -
Permission granted by GE HealthCare
Q&AFriday Q&A: GE HealthCare’s Yoder on using AI to drive precision care
The healthcare technology and diagnostics firm, now a standalone company, will integrate the acquisition of AI software developer Caption Health under Yoder’s lead.
By Susan Kelly • Feb. 23, 2023 -
Courtesy of Labcorp
Labcorp expects 2023 revenue growth, helped by Ascension testing agreement
The company’s business model is shifting as the diagnostics firm prepares to spin off its drug development business and expands management of hospital testing labs.
By Elise Reuter • Feb. 16, 2023 -
Baxter, Abbott, Thermo Fisher among medtech firms cutting jobs on supply issues, slide in testing
"What COVID gave to diagnostics companies, COVID taketh away now that the virus is endemic,” said one analyst.
By Susan Kelly • Updated Feb. 13, 2023 -
Courtesy of Illumina
Illumina posts sales slump in Q4, bets on new sequencing machine to drive 2023 growth
Management is looking to the newly launched NovaSeq X system to help return the company to profitability this year.
By Nick Paul Taylor • Feb. 8, 2023 -
Christopher Furlong via Getty Images
UK health system, under strain, lays out medtech strategy
The state-run National Health Service, now facing a strike by nurses and paramedics, hopes new technologies will help solve some of its long-term challenges to improve patient care.
By Susan Kelly • Feb. 7, 2023 -
Courtesy of GuardantHealth
Diagnostic firms turn to restructuring in bid to preserve cash: Goldman
The moves could lead to underfunding, delay or cancellation of research and development projects, the analysts say.
By Nick Paul Taylor • Feb. 7, 2023 -
Getty Images
Medtech earnings highlights: Easing of macro pressures, accelerated growth in 2023
Still, the latest round of quarterly results show that hospital staffing and supply chain remain a challenge.
By Nick Paul Taylor • Feb. 6, 2023
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