Diagnostics: Page 10
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FDA holds firm on 60-day comment period for lab-developed test rule
The agency is proposing to expand its oversight of tests made by laboratories because it says risks associated with the diagnostics have increased.
By Susan Kelly • Nov. 1, 2023 -
Thermo Fisher cuts 2023 forecast, citing volatile economic conditions
Customer spending remains constrained overall, while economic conditions in China have weakened, CEO Marc Casper said on a Wednesday earnings call.
By Susan Kelly • Oct. 25, 2023 -
Explore the Trendline➔
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TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Courtesy of Illumina
Icahn sues to remove Illumina board members, asks for at least $476M in damages
The activist investor claims board members breached their duties in the acquisition of Grail.
By Nick Paul Taylor • Oct. 24, 2023 -
Courtesy of Abcam
Danaher Q3 revenue declines as demand challenges continue
Better-than-expected respiratory testing revenue was a bright spot, but the company’s overall orders are “bouncing along” at a bottom, CEO Rainer Blair said on a Tuesday earnings call.
By Susan Kelly • Oct. 24, 2023 -
Scott Olson via Getty Images
US trade commission explores impact of patent rules on COVID diagnostics
The USITC report presents conflicting testimony from the medtech industry and advocacy groups about the impact of compulsory licensing.
By Nick Paul Taylor • Oct. 23, 2023 -
Courtesy of Abbott
Abbott raises outlook amid strong Q3, sees momentum into 2024
Sales of the FreeStyle Libre continuous glucose monitor rose nearly 31% despite investor worries about the potential impact of weight-loss drugs on demand.
By Susan Kelly • Oct. 18, 2023 -
Spencer Platt via Getty Images
Siemens Healthineers partners to improve tuberculosis screening using AI
The company will work with the Global Fund to Fight AIDS, Tuberculosis and Malaria, providing free licenses and helping to integrate AI-enabled processes into clinicians’ workflows.
By Nick Paul Taylor • Oct. 18, 2023 -
Courtesy of Thermo Fisher Scientific
Thermo Fisher buys Olink Holding for $3.1B, pushing further into proteomics
Olink’s high-throughput protein analysis technology is expected to complement Thermo Fisher’s mass spectrometry and life sciences platforms.
By Susan Kelly • Oct. 17, 2023 -
Courtesy of BusinessWire/Masimo
Masimo wins de novo authorization for measure of high blood oxygen levels
The ORi device is intended to support standard pulse oximetry by providing additional insights into patients with higher than normal oxygenation.
By Nick Paul Taylor • Oct. 16, 2023 -
Courtesy of Grail
Illumina details EC timeline, funding requirements for Grail divestment
The European Commission ordered the gene sequencing company to support Grail with two-and-a-half years of funding if it pursues a spinoff.
By Susan Kelly • Oct. 13, 2023 -
ArtemisDiana via Getty Images
FDA prioritizes guidance on AI, cybersecurity, pulse oximeters in stacked schedule for 2024
The administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for the upcoming financial year.
By Nick Paul Taylor • Oct. 13, 2023 -
European Commission orders Illumina to divest Grail
The order includes an undisclosed timeline and potential additional fines. Illumina, which has been anticipating the decision, maintains the commission does not have jurisdiction over the completed merger.
By Susan Kelly • Oct. 12, 2023 -
Courtesy of Grail
EU poised to mandate Illumina sell Grail liquid biopsy unit: FT
Regulators could order the divestment of the business as soon as next week to punish Illumina for defying their authority and “illegally” acquiring Grail.
By Nick Paul Taylor • Oct. 10, 2023 -
Permission granted by Delfi
Delfi launches lung cancer blood test based on DNA fragmentation
The test, FirstLook Lung, applies machine learning to whole-genome sequencing data to identify cfDNA patterns associated with lung cancer.
By Nick Paul Taylor • Updated Oct. 9, 2023 -
Permission granted by GE HealthCare
Q&AGE HealthCare imaging CEO Jan Makela talks Mayo Clinic partnership
GE and Mayo Clinic plan to collaborate on imaging, artificial intelligence and cancer treatment.
By Elise Reuter • Oct. 6, 2023 -
Permission granted by Precede Biosciences. Photography by Kim Indresano.
Dana-Farber spinout Precede exits stealth with blood test technology and $57M
Precede has used the money to develop a platform that reveals the activity of genes and pathways.
By Nick Paul Taylor • Oct. 5, 2023 -
Justin Sullivan via Getty Images
Labcorp buys Baystate’s outreach lab business, furthering consolidation blitz
The deal, Labcorp’s fourth outreach takeover since May, will give the company control of service centers in Massachusetts.
By Nick Paul Taylor • Oct. 5, 2023 -
Retrieved from Adobe Stock.
Duke researchers find app improves autism screening in NIH-funded study
Participants who screened positive for autism had a nearly 41% probability of being diagnosed with the condition.
By Nick Paul Taylor • Oct. 4, 2023 -
freepik.com/kjpargeter
Invitae test for hereditary cancers gains FDA de novo nod
The test analyzes DNA from a single blood sample to identify hundreds of variants in 47 genes associated with predispositions for a range of cancer types.
By Susan Kelly • Oct. 3, 2023 -
Permission granted by Mayo Clinic
Mayo Clinic partner earns 510(k) clearance for heart failure screening algorithm
The algorithm analyzes 12-lead ECGs to show if a patient may be developing heart failure.
By Nick Paul Taylor • Oct. 2, 2023 -
Permission granted by Veeva Systems
FDA to regulate lab-developed tests under proposed rule
The tests have come under scrutiny by the agency and lawmakers, but the FDA is still likely to face pushback on the changes.
By Elise Reuter • Sept. 29, 2023 -
Sarah Silbiger via Getty Images
FDA posts guidance on how to simplify updates to antimicrobial resistance tests
The advice focuses on predetermined change control plans, a mechanism the regulator sees as a way to streamline updates in multiple areas.
By Nick Paul Taylor • Sept. 29, 2023 -
Dmitry Belyaev via Getty Images
Harbinger Health raises $140M to study blood-based cancer screening test
The test developer will use the series B funding to complete a 10,000-subject clinical trial ahead of a planned launch in 2025.
By Nick Paul Taylor • Sept. 28, 2023 -
Sarah Silbiger via Getty Images
FDA shares draft medical device harmonization plan to meet MDUFA V goal
The FDA outlined deadlines for actions it will take, including creating a mechanism for working with regulatory partners.
By Nick Paul Taylor • Sept. 25, 2023 -
Courtesy of Hologic
Hologic allies with Bayer to support uptake of contrast-enhanced mammography
The companies will provide a product package and training intended to support adoption of the imaging technique.
By Nick Paul Taylor • Sept. 22, 2023
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