Diagnostics: Page 2
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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 -
Explore the Trendline➔
Kendall Davis/MedTech Dive, original photos courtesy of Abbott and Dexcom
TrendlineThe MedTech Dive Outlook on 2021
The pandemic will keep disrupting the industry in the year ahead, as COVID-19 testing wanes and elective procedures slowly ease back. We look at the risks, challenges and opportunities.
By MedTech Dive staff -
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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 -
Nuthawut Somsuk via Getty Images
Is bigger better? McKinsey predicts the return of large medtech mergers
The analysts argue that pressure to improve margins and become the partner of choice to hospitals favors large deals.
By Nick Paul Taylor • Sept. 22, 2023 -
"Government Accountability Office Building" by kafka4prez is licensed under CC BY-SA 2.0
Limited resources constrain federal oversight of medical device ads, GAO finds
U.S. agencies took 322 enforcement actions related to medtech advertising between 2018 and 2022.
By Nick Paul Taylor • Sept. 21, 2023 -
Stefan Zaklin via Getty Images
CMS leader defends breakthrough device reimbursement proposal at House hearing
Dora Hughes made the case for restricting the Transitional Coverage for Emerging Technologies pathway to five reviews a year.
By Nick Paul Taylor • Sept. 20, 2023 -
artJazz via Getty Images
MedTech Europe says MDR, IVDR framework needs ‘structural reform’
Patients may face delayed access to treatments unless changes are made to the new regulatory system, 35 European trade groups warned in an open letter.
By Susan Kelly • Sept. 18, 2023 -
Sara Silbiger via Getty Images
FDA finalizes breakthrough device changes to target health inequities
The proposals received positive feedback from groups including AdvaMed, leading the FDA to finalize the changes with only minor revisions.
By Nick Paul Taylor • Sept. 18, 2023 -
Courtesy of GE HealthCare
GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI
The organizations will collaborate on the application of AI to MRI and the automation of diagnostic and interventional ultrasound.
By Nick Paul Taylor • Sept. 15, 2023 -
Thomas Andreas via Getty Images
Study suggests AI could provide second reading of mammograms
In a separate commentary, researchers described the study as launching “the arrival of prospective trials of AI in the breast screening setting.”
By Elise Reuter • Sept. 12, 2023 -
Joe Raedle via Getty Images
Walgreens to pay $44M to settle claims over fraudulent Theranos tests
If a judge approves the settlement, patients who bought a Theranos blood test would receive double the amount they paid for it.
By Elise Reuter • Sept. 8, 2023 -
Courtesy of Paige
Microsoft, Paige team to use supercomputers to train cancer pathology AI models
Microsoft will support development of a new model that is “orders-of-magnitude larger” than any in use today.
By Nick Paul Taylor • Sept. 8, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA proposes 3 guidances to improve 510(k) clearance process
The agency has made recommendations for selecting predicate devices, using clinical data and conducting performance testing for implants.
By Nick Paul Taylor • Sept. 7, 2023 -
Courtesy of Cue Health Press Kit
Cue Health board pressured by investor to review strategy, cut costs
Tarsadia Investments called for the board to “take immediate action to prevent further destruction of stockholder value.”
By Nick Paul Taylor • Sept. 6, 2023 -
Courtesy of GuardantHealth
Guardant abandons cancer blood test trial early, restates confidence in product line
Guardant stopped enrolling new patients in the study because of its design and use of an older generation test, analysts said.
By Nick Paul Taylor • Sept. 6, 2023 -
Permission granted by Illumina
Illumina names Agilent’s Jacob Thaysen as its next CEO
The appointment comes less than three months after former CEO Francis deSouza stepped down following a proxy battle.
By Susan Kelly • Sept. 5, 2023 -
Courtesy of 23andMe
23andMe wins FDA clearance to test for expanded set of BRCA cancer risk variants
The new version of the test can report more cancer-related gene mutations, and 23andMe can add variants in the future under an agreement with the FDA.
By Nick Paul Taylor • Sept. 5, 2023 -
Permission granted by Noah Medical
Noah Medical lung biopsy robot exceeds expectations in first-in-human trial
The startup presented early data on its FDA-cleared system at a meeting of pulmonologists in Chicago.
By Susan Kelly • Sept. 1, 2023 -
SHansche via Getty Images
UK regulators name 3 approved bodies to ease device certification bottleneck
A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.”
By Nick Paul Taylor • Aug. 31, 2023
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