Diagnostics: Page 57
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Illumina-backed study finds limited role for liquid biopsy in lung cancer
The "modest" true positive rate achieved by the blood test may limit its usefulness.
By Nick Paul Taylor • March 21, 2019 -
UK steps up no-deal planning as Brexit clock ticks down
MHRA updated its advice on registering devices against a backdrop of concerns about supply disruptions.
By Nick Paul Taylor • March 21, 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 -
Lab industry pushes CMS to withdraw 'highly disruptive' coding changes
Nine trade groups called for reversal of certain lab and pathology section updates to National Correct Coding Initiative policy manuals.
By Nick Paul Taylor • March 20, 2019 -
Abbott gets CE mark for molecular diagnostics machine
The device expands the company's fast-selling portfolio of Alinity laboratory testing instruments.
By Nick Paul Taylor • March 20, 2019 -
Analysts tip UnitedHealth's preferred lab network to boost LabCorp, Quest
The big insurer will create a subgroup of lower-cost providers, which may help the lab giants win business from less-efficient competitors, according to investment bank Jefferies.
By Nick Paul Taylor • March 19, 2019 -
Breast implants, metal hips and other device materials under new FDA scrutiny
Symptoms such as fatigue, rash, joint and muscle pain or weakness may not appear until years after a device is implanted, FDA said.
By David Lim • March 18, 2019 -
Navigating FDA's evolving device pathways: A primer
The agency is touting the biggest alterations to medtech approval processes in the decades since it began reviewing devices. Here's a roundup of the current regulatory framework and what's potentially changing.
By Meg Bryant • March 13, 2019 -
Omada adds connected blood pressure cuff, glucometer to health program
The devices will enable participants in the digital health platform's disease prevention and management program to collect and share data.
By Nick Paul Taylor • March 13, 2019 -
Diagnostic errors compounded by EHRs No. 1 safety fear: ECRI
"We have to recognize the limits of current technology and ensure that we have processes in place to close the loop on diagnostic tests," the medical device watchdog's William Marcella said.
By Meg Bryant • March 12, 2019 -
NCI Director Ned Sharpless to be named FDA acting commissioner
Sharpless will succeed FDA Commissioner Scott Gottlieb in early April. He has served as director of the National Cancer Institute since October 2017.
By David Lim , Maria Rachal • Updated March 12, 2019 -
NCI Director Ned Sharpless to be FDA acting commissioner
Sharpless will succeed FDA Commissioner Scott Gottlieb in early April. He has served as director of the National Cancer Institute since October 2017.
By Maria Rachal • March 12, 2019 -
23andMe to gauge Type 2 diabetes risk
The genetic testing company sees a big market opportunity in the chronic disease and argues risk is currently underscreened.
By Maria Rachal • March 11, 2019 -
Roche wins first immunotherapy approval for triple-negative breast cancer
On Monday Roche announced its Ventana PD-L1 Assay was approved as the first companion diagnostic to identify triple-negative breast cancer patients for the Tecentriq-Abraxane combination.
By Ned Pagliarulo • Updated March 11, 2019 -
AI tool for cancer diagnosis wins FDA breakthrough status
Startup Paige.AI, through a licensing agreement with Memorial Sloan Kettering Cancer Center, is developing a portfolio of artificial intelligence-based products for use in the diagnosis of a range of cancers, starting with prostate cancer.
By Susan Kelly • March 8, 2019 -
Oral arguments in ACLA v. Azar appeal set for April 23
In a brief, HHS argued the American Clinical Laboratory Association does not have standing to bring a lawsuit over implementation of the Protecting Access to Medicare Act.
By David Lim • March 7, 2019 -
FDA advisers weigh in on HPV screens
The non-voting advisory committee's recommendations aimed to broaden clinical study participation and predicate evaluation of new tests on relative performance against a clinical endpoint comparator.
By Maria Rachal • Updated March 19, 2019 -
Ascension hospital network taps Abbott diagnostics for lab work
The deal will put Abbott's Alinity diagnostic systems to work for an additional 2.4 million patients.
By Susan Kelly • March 6, 2019 -
Machine learning model aims to match pathologists in IDing lung cancer
In an early test, a recently developed neural network proved to be "statistically on par" with the expertise of three pathologists in classifying lung cancer slides.
By Nick Paul Taylor • March 5, 2019 -
Blood test identifies proteins to predict preterm birth
Researchers found that five circulating microparticle proteins in first trimester blood samples could help predict risk, including among first-time mothers.
By Susan Kelly • March 4, 2019 -
Liquid biopsy as effective as tissue biopsy in lung cancer, study finds
A clinical trial found Guardant Health's test detected advanced non-small cell lung cancer at a similar rate to traditional tissue-based biopsies.
By Emily Mullin • March 1, 2019 -
Gene test for antibiotic resistance gets FDA breakthrough nod
The World Health Organization has identified antibiotic resistance as one of the biggest threats to global health.
By Susan Kelly • March 1, 2019 -
Thermo Fisher lung cancer test wins expanded approval in Japan
Japan's regulatory agency approved the Oncomine DX Target test to include three additional biomarkers for non-small cell lung cancer.
By Susan Kelly • Feb. 27, 2019 -
Feds team up to speed diagnostic testing access in emergencies
Labs using an in vitro diagnostic granted an Emergency Use Authorization must still comply with Clinical Laboratory Improvement Amendments regulations.
By David Lim • Feb. 27, 2019 -
Myriad plans companion diagnostic filing as PARP drug clears clinical test
The company said Thursday its BRACAnalysis CDx diagnostic will be used to find germline BRCA mutations in men with certain prostate cancers in a Phase 3 study.
By Nick Paul Taylor • Updated April 4, 2019 -
Verily launches eye disease screening algorithm in India
The company also said the algorithm won CE mark approval, but did not reveal its plans for the technology in Europe.
By Susan Kelly • Feb. 26, 2019
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