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

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

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

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

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

Medtech R&D adapting under new pressures, industry study shows

The shift to value-based payment models and already tight profit margins are ratcheting up pressure, but the device makers are adjusting their R&D investment strategies in response.

By Susan Kelly • Dec. 4, 2018

Medicare could overpay billions for lab tests: GAO

Medicare's new method of calculating payment rates for laboratory tests was intended to save the government money but could instead end up costing CMS as much as $10.3 billion over three years.

By Susan Kelly • Dec. 3, 2018

FDA OKs first test to detect herpes in newborns

The Meridian Bioscience test uses a saliva swab to detect cytomegalovirus DNA and may help identify the virus in newborns more quickly.

By Susan Kelly • Dec. 3, 2018