Diagnostics: Page 59
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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 -
Deep Dive
How 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 -
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 -
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. 9, 2019 -
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. 9, 2019 -
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. 8, 2019 -
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. 7, 2019 -
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. 4, 2019 -
Deep Dive
What'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. 3, 2019 -
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. 3, 2019 -
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, 2018 -
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 -
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 -
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 -
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 -
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 -
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 -
Grand jury indicts physician over alleged medical testing fraud
The indictment came days before the government settled a separate fraud case with an audiology practice.
By Nick Paul Taylor • Dec. 13, 2018 -
Apple EKG, artificial iris among FDA 2018 device decisions
De Novos are on the rise, but both premarket approvals and 510(k)s appear to be slightly down from 2017, according to nearly year-end data from FDA.
By Meg Bryant • Dec. 12, 2018 -
Courtesy of Merck & Co.
Merck taps Roche for Keytruda companion diagnostic
Roche will develop a test to identify patients with a certain biomarker known to make solid tumors vulnerable to treatment with the checkpoint inhibitor.
By Nick Paul Taylor • Dec. 12, 2018 -
Thermo Fisher gets FDA nod for plazomicin immunoassay
The antibiotic, marketed as Zemdri, is used to treat patients with complicated urinary tract infections.
By Susan Kelly • Dec. 11, 2018 -
Hologic begins selling 3-in-1 uterine scope
The device is intended to improve the procedure for treating uterine conditions by avoiding the need to change from a diagnostic to an operative scope.
By Susan Kelly • Dec. 11, 2018 -
FDA guide unveils vision for cancer diagnostics
The proposal came the same day lawmakers released an updated draft bill that would grant FDA authority to oversee in vitro clinical tests, such as test kits and laboratory developed tests.
By David Lim • Dec. 7, 2018 -
FDA endorses open database for genetic variants
The agency said it hopes the move will encourage database administrators to submit genetic variant information to publicly accessible databases, with the aim of spurring advancements in precision medicine.
By Susan Kelly • Dec. 5, 2018 -
ACLA appeals lab payment suit to higher court
A watchdog report on Medicare lab payments will not help the industry's case, analysts said.
By David Lim • Dec. 5, 2018
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