Diagnostics: Page 57
-
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 -
FDA warns breast infrared imaging tool should not replace mammography
Total Thermal Imaging's thermography system has not been cleared as a standalone diagnostic tool, and the technology lacks scientific evidence to support its use in breast cancer screening, the agency said.
By Susan Kelly • Feb. 26, 2019 -
Philips' camera-guided digital imaging system gets FDA OK
The nod comes after Philips reported fourth quarter growth in image-guided therapy, ultrasound and diagnostic imaging.
By Meg Bryant • Feb. 21, 2019 -
Intuitive gains FDA clearance for Ion lung catheter
The robot-assisted surgery pioneer said it plans a measured U.S. rollout of the system with customer shipments beginning in the second quarter.
By Susan Kelly • Feb. 20, 2019 -
ACLA, AdvaMedDx clash on lab test overhaul bill
The latest version of draft legislation incorporated suggestions from FDA, including a precertification program. The Pew Charitable Trusts cautioned that may open up patients to risk from unreviewed products.
By David Lim • Feb. 20, 2019 -
FDA grants breakthrough status to concussion-detecting VR headset
The SyncThink device analyzes the wearer's eye movements. The medtech has deals with the Golden State Warriors and hospitals including Mass General.
By Nick Paul Taylor • Feb. 20, 2019 -
FDA grants breakthrough status to amyloid beta Alzheimer's test
The assay analyzes the ratio of two forms of amyloid beta in cerebrospinal fluid to help determine if a patient has Alzheimer's.
By Nick Paul Taylor • Feb. 15, 2019 -
Headwinds stiffen as Quest revenues, earnings miss Q4 estimates
Elements of the fourth quarter financial results align with performance of chief rival LabCorp. Both companies are contending with Medicare rate reductions as a result of PAMA.
By Nick Paul Taylor • Feb. 14, 2019 -
Software products face high-risk upclassing in Australia
The Therapeutic Goods Administration wants to significantly increase the regulatory burden on medical software, with some products potentially jumping from the lowest to highest risk category.
By Nick Paul Taylor • Feb. 14, 2019 -
GenomeDx pays $2M to settle genetic test false claims allegations
The U.S. government accused the company of billing Medicare for unnecessary prostate cancer tests.
By Nick Paul Taylor • Feb. 13, 2019 -
Industry strikes back at GAO's 'flawed and dangerous' PAMA report
AdvaMedDx and the other trade groups want to meet with the watchdog to discuss the dispute over the contention the payment law would cost Medicare billions rather than save.
By Nick Paul Taylor • Feb. 13, 2019 -
Rapid test for brain injury gets FDA breakthrough status
The test measures protein biomarkers released from the brain into the bloodstream after a head trauma, producing results in as little as 90 seconds.
By Susan Kelly • Feb. 12, 2019 -
LabCorp diagnostics' operating income tumbles as PAMA hits home
Reimbursement changes wiped $18 million off LabCorp's adjusted operating income, contributing to a 22% drop at the diagnostics unit.
By Nick Paul Taylor • Feb. 7, 2019 -
FDA categorizes Edwards' cardiac diagnostic recall as Class I event
Edwards pulled the catheters from the market after learning that an assembly error was causing the devices to display inaccurate information.
By Nick Paul Taylor • Feb. 7, 2019
Previous
