Diagnostics
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Early A1C test may reduce gestational diabetes risk: NIH study
The NIH researchers analyzed records from the NICHD Fetal Growth Study of more than 2,000 low-risk pregnant women from 12 U.S. clinical sites between 2009 and 2013.
By Susan Kelly • Aug. 17, 2018
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DeepMind's AI detects over 50 eye diseases with 94% accuracy, study shows
The work is a collaboration between Google's DeepMind subsidiary, Moorfields Eye Hospital and University College London to speed diagnosis and referrals for sight-threatening eye diseases.
By Meg Bryant • Aug. 15, 2018
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AdvaMed pushes back against FDA humanitarian device guidance
The trade group thinks the guidance will deter development of devices to treat rare conditions.
By Nick Paul Taylor • Aug. 15, 2018
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Deep DiveMedical device industry caught in US-China trade war
"If this keeps escalating … a tit-for-tat game without any end in sight, that's very concerning to our industry and ultimately to patient care," a top industry imaging official said.
By Meg Bryant • Aug. 13, 2018
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FDA warns manufacturing fault with membrane test creates fetal death risk
The rupture test results could be misinterpreted, leading to serious adverse events.
By Nick Paul Taylor • Aug. 09, 2018
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Boston Children's expands sequencing of patients with epilepsy, IBD
The hospital hopes to learn more about disease pathways and identify novel drug targets.
By Nick Paul Taylor • Aug. 08, 2018
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New blood test can rule out heart attack faster
The new test showed greater sensitivity and precision than the fourth-generation conventional test currently in use in the United States.
By Susan Kelly • Aug. 07, 2018
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UK regulators reassure medtech sector about Brexit impact
The MHRA expects little to change until 2021 but the risk of significant near-term upheaval remains.
By Nick Paul Taylor • Aug. 07, 2018
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Industry urges Congress to ease clinical lab pay cuts
The medical device and hospital industries are among those arguing that under the first six months of new reimbursement rates, labs have cut staff, resulting in limited or ended home care visits for homebound patients.
By David Lim • Aug. 03, 2018
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Bio-Techne closes $250M Exosome Diagnostics takeover
The acquisition moves the company into the nascent liquid biopsy sector.
By Nick Paul Taylor • Aug. 03, 2018
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Siemens Healthineers hits Q3 goals as imaging sales rise
Demand for molecular imaging, X-ray products and magnetic resonance drove growth.
By Nick Paul Taylor • Aug. 02, 2018
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MedTech Europe seeks 'urgent' changes to EU regs deadlines
The trade group proposes either stopping the clock on the countdown to the end of the transition periods or delaying the implementation dates for all products, or just legacy products.
By Nick Paul Taylor • July 31, 2018
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ECRI safety panel advises 3 ways to avoid diagnostic testing, medicine mix-ups
"The problem of not closing the loop has a significant impact on patients and caregivers, and can lead to devastating effects on the outcome of patients, workgroup chair Chris Lehmann said.
By David Lim • July 27, 2018
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IBM's Watson gave 'unsafe and incorrect' cancer treatment advice: STAT report
No patients died as a result of inaccurate recommendations, according to internal documents obtained by the news organization.
By Meg Bryant • July 26, 2018
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GSK teams up with 23andMe to boost R&D
As part of a broader restructuring, the British pharma hopes to tap 23andMe's genetic database to develop better drugs and more easily find patients.
By Lisa LaMotta • July 25, 2018
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LabCorp lowers 2018 diagnostics arm growth guidance
The unit saw a drop in adjusted operating income, attributed to the negative impact from the Protecting Access to Medicare Act.
By David Lim • July 25, 2018
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Quest Diagnostics posts slight Q2 revenue miss
CEO Stephen Rusckowski said the company welcomes CMS' recent proposal to change how it collects clinical laboratory fee data.
By Susan Kelly • July 24, 2018
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5 key parts of the FDA Medical Device Safety Action Plan
The ambitious proposal focuses on a total lifecycle approach to device safety.
By Meg Bryant • July 23, 2018
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LabCorp shuts down IT system after possible hack attack
The company's response delayed the transmission of test results to customers.
By Nick Paul Taylor • July 19, 2018
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Abbott beats expectations as sales of diabetes device soar
Glucose monitor FreeStyle Libre drove 40% growth at the diabetes unit, the company's best performer.
By Nick Paul Taylor • July 19, 2018
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CMS targets data gaps in setting lab payments
The American Clinical Laboratory Association said it "will urge Congress as well as CMS to address significant shortfalls in the data collection process that jeopardize care for the most vulnerable seniors."
By Susan Kelly • July 16, 2018
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Deep DiveTransition clock ticking on new EU device regs
"It's a problem because how do you comply with a new standard when you don't know what the standard is?" said AdvaMed's Joe Gatewood.
By Meg Bryant • July 16, 2018
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Feds pump $24M into development of at-home flu tests
Cue Health and Diassess will split the funding. The government thinks the diagnostics could curb the spread of pandemic viruses.
By Nick Paul Taylor • July 12, 2018
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Wearable ECG patch increases atrial fibrillation diagnosis in clinical trial
Use of a digital health device has increased diagnosis of atrial fibrillation, raising hopes that stroke risk can be reduced.
By Nick Paul Taylor • July 11, 2018
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Data-sharing site seeks to battle underground chemists in opioid fight
US agencies are teaming with the German government to help forensic chemists share data on new drug variants.
By Susan Kelly