Diagnostics: Page 2
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FDA finalizes guidance on development of antimicrobial tests
The document is intended to improve coordination between drug and diagnostic developers.
By Nick Paul Taylor • Jan. 18, 2019
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Top House Democrat to focus on diagnostics revamp, drug prices in 2019
With Democrats now in power, the new chair of a key oversight subcommittee laid out her priorities, including proposals she argues will bolster the Affordable Care Act.
By David Lim • Jan. 17, 2019
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JAMA study raises questions on lung cancer screening cost-effectiveness
Researchers found complication rates far higher than the National Lung Cancer Screening Trial did in community settings.
By David Lim • Jan. 16, 2019
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After losses to Quest, LabCorp strikes exclusive Texas testing deal
The extension of the long-term relationship comes as LabCorp faces competition for key accounts.
By Nick Paul Taylor • Jan. 16, 2019
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Neural network matches cardiologists in EKG analysis study
Researchers think the algorithm could improve the triaging of patients.
By Nick Paul Taylor • Jan. 16, 2019
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Medtech therapeutic areas to track in 2019
Cardiovascular health, diabetes and oncology diagnostics are among the products with greatest consumer and investor interest.
By Maria Rachal • Jan. 15, 2019
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Uncertainties abound with growing prospect of hard Brexit
The future for medtech companies in Europe was further complicated Tuesday with Britain's government firmly rejecting PM Theresa May's EU exit deal by a vote of 432 to 202, prompting debate of a no-confidence vote Wednesday.
By Meg Bryant • UPDATED: Jan. 16, 2019 at 10 a.m.
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5 medtech trends to watch in 2019
FDA regulatory changes, diagnostics legislation, a sustained focus on cybersecurity, looming European Union regulations and China trade headwinds are likely to take center stage.
By David Lim • Jan. 11, 2019
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NIH researchers develop AI system to improve cervical cancer screening
The system outperformed other tests in the study but needs improvement before being used in practice.
By Nick Paul Taylor • Jan. 11, 2019
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Deep DiveHow AI could shape the health tech landscape in 2019
Highlights include technologies that cut costs and promote patient health, especially in the areas of imaging, diagnostics, predictive analytics and administration.
By Rebecca Pifer • Jan. 10, 2019
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UK updates no-deal Brexit advice as vote on withdrawal agreement nears
Companies will need a designated individual based in the U.K. to register medical devices in the country.
By Nick Paul Taylor • Jan. 10, 2019
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Skin tracker tech debuts at CES
The next frontier for wearables? Skin health, at least for L'Oréal's mobile-paired My Skin Track pH, which captures small amounts of sweat from pores to read acidity levels.
By Robert Williams • Jan. 09, 2019
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LabCorp and Quest prepare for year of M&A as price cuts hit small labs
The laboratory testing giants expect reimbursement reductions to wipe out profits at smaller rivals, triggering a period of heavy consolidation.
By Nick Paul Taylor • Jan. 09, 2019
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Hologic boosts its first-quarter revenue outlook
The device and diagnostics company, which specializes in women's healthcare, attributed the upturn to acceleration in its U.S. breast health, molecular diagnostics and international businesses.
By Susan Kelly • Jan. 08, 2019
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AI with EKG can detect a form of heart disease, research shows
Use of artificial intelligence with an electrocardiogram can create an inexpensive, noninvasive test for asymptomatic left ventricular dysfunction, a precursor to heart failure.
By Susan Kelly • Jan. 07, 2019
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LabCorp inks licensing pact for Genfit liver test
The deal is expected to drive use of Genfit's non-invasive, biomarker test for the liver disease non-alcoholic steatohepatitis in the clinical research market.
By Susan Kelly • Jan. 04, 2019
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Deep DiveWhat's in a connected medical device? Cybersecurity regulators want to know
FDA could require device makers to publicize a software bill of materials as early as the premarket application process to more quickly identify vulnerabilities in the event of a cyberattack.
By Meg Bryant • Jan. 03, 2019
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Concussion diagnostic tech on rise with FDA clearances
Two neurodiagnostic device companies announced marketing authorizations this week, with both touting a shift toward using clearer evidence-based technologies when addressing brain injuries.
By Maria Rachal • Jan. 03, 2019
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CMS sets user fee increase for CLIA-certified labs
User fees will go up 20%, the first increase in two decades, to cover general program administration costs.
By Susan Kelly • Dec. 31, 2019
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Regulatory makeovers and international game changers: MedTech Dive's top stories of 2018
Hard looks at cybersecurity and digital health's hot streak also left their mark on the year.
By Maria Rachal • Dec. 22, 2018
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FDA-cleared, wearable blood pressure device hits market
A cuff in the wrist watch band inflates to capture systolic and diastolic pressure.
By Maria Rachal • Dec. 21, 2018
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BD gets 510(k) for viral gastroenteritis diagnostic
The panel reportedly delivers results in less than 3.5 hours.
By Maria Rachal • Dec. 21, 2018
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Researchers advance 3D-printed, wirelessly-controlled ingestible
The multi-purpose device could spend a month or more in the stomach as a diagnostic tool or drug delivery mechanism.
By Nick Paul Taylor • Dec. 19, 2018
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FDA draft guidance aims to clarify X-ray radiation rules
The agency also said it plans to harmonize its performance standards with those of the International Electrotechnical Commission to simplify compliance for global manufacturers.
By Susan Kelly • Dec. 17, 2018
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Rapid diagnostic test detects Ebola, malaria in the field
The portable test can detect Ebola and other viruses in under 30 minutes from a single blood sample.
By Susan Kelly • Dec. 14, 2018