Diagnostics: Page 54
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Abbott teases FreeStyle Libre potential beyond glucose monitoring
The company is expanding manufacturing of its blockbuster diabetes device, a technology CEO Miles White said could be expanded to track other analytes.
By Maria Rachal • July 17, 2019 -
Hospitals may boost outsourcing of lab services: UBS poll
LabCorp may benefit most from the increasing use of service providers, with nearly 10% more respondents expressing interest in working with the company over rival Quest Diagnostics.
By Nick Paul Taylor • July 17, 2019 -
Explore the Trendline➔
Sara Silbiger via Getty Images
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 -
Screenings fail to explain rise in colorectal cancer in younger adults, study finds
The American Cancer Society called for further study of the trend, saying factors beyond expanded use of colonoscopy testing may play a role in driving the increased incidence of colorectal cancer.
By Susan Kelly • July 15, 2019 -
WHO expands lists of essential in vitro diagnostics
New additions include 12 tests for detection of solid tumors like colorectal, liver, cervical, prostate, breast, germ cell and blood cancers, as well as lymphomas.
By Susan Kelly • July 10, 2019 -
Fitch Solutions tips Roche to challenge Philips for digital pathology market
After enjoying a brief monopoly, Philips faces a clutch of competitors planning regulatory filings.
By Nick Paul Taylor • July 10, 2019 -
Investment firm downgrades Myriad Genetics as growth thesis weakens
Cowen analysts made the decision in light of back-to-back quarters in which sales of key products fell short of expectations.
By Nick Paul Taylor • July 10, 2019 -
House lawmakers introduce bill to delay PAMA data collection
The clinical laboratory industry praised the legislation, which also calls on the National Academy of Medicine to make recommendations on how to improve the data collection process.
By Susan Kelly • July 1, 2019 -
Hologic promotes replacement to head diagnostics unit
Kevin Thornal, who is currently the president of the company's medical aesthetics division, will become the president of its diagnostics unit.
By Nick Paul Taylor • Updated July 22, 2019 -
OncoCyte delays liquid biopsy test for lung cancer again
The company expected to complete key studies around the middle of 2019 and bring the test to market by year's end, but has now abandoned the target.
By Nick Paul Taylor • June 27, 2019 -
MRI as safe as cardiac catheterization for coronary disease screening: NEJM
The study's author hopes less-invasive MRI scans will become more widely used for making treatment decisions for patients with stable chest pain, reducing the need for cardiac catheterization.
By Susan Kelly • June 25, 2019 -
Roche assay identifies Alzheimer's biomarker in blood samples
The assay predicted beta-amyloid status but fell short of being accurate enough to independently confirm the presence of the biomarker, according to research published in JAMA Neurology.
By Nick Paul Taylor • June 25, 2019 -
Cardiology practice pays $2.5M to settle case involving genetic testing kickback allegations
In the latest case involving improper billing of Medicare for genetic tests, Nevada Heart & Vascular Center allegedly referred patients to Natural Molecular Testing and Iverson Genetic Diagnostics for payments.
By Nick Paul Taylor • June 20, 2019 -
Mount Sinai joins LabCorp to adopt Philips' digital pathology
The clinical lab giant will integrate the system into Mount Sinai’s eight hospitals, enabling remote review of images and surgical slides.
By Nick Paul Taylor • June 19, 2019 -
Bio-Techne gains breakthrough status for liquid biopsy prostate test
The test analyzes a patient's exosomes to help doctors determine whether a prostate biopsy is needed in patients with an ambiguous PSA test result.
By Susan Kelly • June 18, 2019 -
Lloyd's exits notified body services, leaving UK with 3
The withdrawal comes as Europe faces major concerns about capacity ahead of the new MDR and IVD regs.
By Nick Paul Taylor • June 14, 2019 -
FDA issues draft advice on biotin interference with diagnostic testing
A 2017 agency safety communication reported a patient dying after high levels of biotin interference resulted in falsely low troponin results. Troponin tests are often used to detect heart attacks.
By David Lim • June 13, 2019 -
AMA adopts measures to shape development, uptake of AI systems in healthcare
The policies seek to ensure developers of AI, not physicians, are liable for medical errors involving the technologies.
By Nick Paul Taylor • June 13, 2019 -
OIG estimates Medicare overpaid $269M for sleep studies
OIG thinks the problems occurred because CMS failed to provide the oversight needed to stop payments for noncompliant claims.
By Nick Paul Taylor • June 13, 2019 -
Antibiotic resistance test for gonorrhea gets FDA breakthrough nod
Australia's SpeeDx received the expedited review for a molecular test that detects both N. gonorrhea and a patient's susceptibility or resistance to the antibiotic ciprofloxacin.
By Susan Kelly • June 12, 2019 -
Germany, Ireland push EU to assess device regs preparedness
The delegations think a significant reduction in notified bodies is likely but hope to avoid delaying implementation "unless absolutely necessary."
By Nick Paul Taylor • June 12, 2019 -
Pathology group sets expectations for DTC genetic tests
Amid a growing market for direct-to-consumer genetic tests, the Association for Molecular Pathology urged additional standards for test providers to meet.
By Susan Kelly • June 11, 2019 -
Roche Diagnostics names Schinecker as new CEO
The appointment concludes a transitionary period for the company's diagnostic unit following the August exit of former CEO Roland Diggelmann, who served in the position for 10 years.
By David Lim • June 11, 2019 -
Quest, LabCorp breach stirs questions of cybersecurity risk from outside vendors
The breach could result in new regulations and rules governing how U.S. companies select and assess their vendors, according to Moody's.
By Rebecca Pifer • Updated June 11, 2019 -
Harvard's Wyss Institute receives $131M gift
The contribution comes from founder Hansjörg Wyss, the former CEO of Swiss device maker Synthes, whose vision for the institute has led to several medical breakthroughs over the past decade.
By Susan Kelly • June 10, 2019 -
Concussion test gets breakthrough nod in fast-growing field
Brain Box's test diagnoses and rates the severity of traumatic brain injury, the incidence of which is on the rise.
By Susan Kelly • June 7, 2019
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