Thermo Fisher expands peanut allergy test menu

The company hopes the assay will lead to more tailored, effective allergy management strategies.

By Nick Paul Taylor • Jan. 24, 2019

Illumina TruSight assay gets FDA breakthrough designation

The DNA sequencing company is seeking clearance of the assay as a companion diagnostic.

By Susan Kelly • Jan. 23, 2019

Explore the Trendline➔

Top 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

Hereditary colorectal cancer screen is 23andMe's latest FDA nod

The test will look at the two most common genetic variants influencing MUTYH-associated polyposis, which can indicate heightened risk for cancers of the colon, rectum and thyroid.

By Maria Rachal • Jan. 23, 2019

Abbott misses sales expectations despite device, diagnostic unit growth

The medical device unit had the strongest quarter of four divisions, with double-digit growth in sales of diabetes, electrophysiology and structural heart products fueling its performance.

By Nick Paul Taylor • Jan. 23, 2019

J&J to study Apple Watch with heart health app

That medtech giant said it would investigate how the product can be used by seniors to flag atrial fibrillation and prevent stroke in conjunction with a J&J heart health app.

By Maria Rachal • Jan. 18, 2019

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

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

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

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

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

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

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

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

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

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

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