Will a big needle burst the NASH bubble?

With less invasive tests still a few years off, doctors worry liver biopsies will limit access to the initial wave of NASH drugs — if any make it to market. 

By Jacob Bell • May 14, 2019

Grail's multi-cancer blood test nabs breakthrough device status

The Bezos and Gates-backed cancer diagnostic developer said the FDA designation will expedite the early detection methylation technology it is testing. Exact Sciences, Guardant Health and others share goals in the space.

By Maria Rachal • Updated May 14, 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

Same-day upper and lower endoscopies improve care, costs: JAMA

Johns Hopkins researchers used Medicare claims data to identify patterns suggesting overuse of different-day scheduling, especially when physician offices and freestanding ambulatory surgery centers did the scheduling.

By Susan Kelly • May 14, 2019

LabCorp to sell Qiagen companion diagnostic for bladder cancer

The test is designed to assess whether patients with urothelial cancer are eligible for treatment with Johnson & Johnson’s newly approved therascreen fibroblast growth factor receptor kinase inhibitor Balversa.

By Susan Kelly • May 13, 2019

Eye scan to detect Alzheimer's biomarker gets breakthrough status

Optina Diagnostics' retinal imaging platform uses artificial intelligence to detect amyloid plaques in the brain and is intended to improve diagnostic accuracy as a non-invasive, low-cost tool.

By Susan Kelly • May 10, 2019

Myriad guidance disappoints investors as pricing pressures dampen expectations

The molecular diagnostic company expects full year EPS to fall well short of the previously forecast range and warned pricing pressures will affect performance in 2020.

By Nick Paul Taylor • May 9, 2019

FDA updates imaging rules in final guidance

The agency aims to align U.S. performance standards for X-ray imaging equipment with international policy, efforts supported by industry groups, and clarify aspects of U.S. requirements for fluoroscopic equipment.

By Susan Kelly • May 8, 2019

Verily's nanoparticle diagnostic program evolves into Verve partnership

Alphabet's life sciences research arm was initially interested in nanoparticle diagnostics but thinks the program has therapeutic potential.

By Nick Paul Taylor • May 8, 2019

ACLA, AdvaMedDx, BIO call for VALID Act movement by year-end

Despite differences between clinical labs and diagnostic manufacturers, industry wants to keep the legislation at the top of mind for Congress before the election and user fee negotiations suck oxygen away from the effort next year. 

By David Lim • May 7, 2019

Test for circulating tumor DNA wins FDA breakthrough designation

Genetic testing company Natera is developing the product to detect and quantify post-surgery ctDNA in the blood of patients already diagnosed with some types of cancer.

By Susan Kelly • May 7, 2019

Test for gene fusions in tumors gains breakthrough status

The assay from Caris Life Sciences is intended to detect fibroblast growth factor receptor biomarkers, including gene fusions, in solid tumors.

By Susan Kelly • May 6, 2019

EU issues device, diagnostics database requirements

The documents detail what data manufacturers will need to include in the European Database on Medical Devices for devices and in vitro diagnostics under its new regulations.  

By Susan Kelly • May 6, 2019

AI diagnostic tool for kidney disease earns breakthrough status

The technology uses electronic health record information and machine learning algorithms to assess blood-based biomarkers and identify patients at risk for kidney disease progression.

By Susan Kelly • May 3, 2019

Abbott gets WHO prequalification for point-of-care HIV test

The diagnostic can expand access to viral load testing in resource-limited settings and improve management of HIV, Abbott said.  

By Nick Paul Taylor • May 3, 2019

CMS reopens coverage determination on next generation sequencing for cancer patients

Healthcare organizations argued the agency's original decision would prevent Medicare beneficiaries with early-stage cancer from accessing NGS tests.

By Susan Kelly • April 30, 2019

LabCorp weathers PAMA, Quest competition to beat expectations

Pricing pressure and competition for UnitedHealth work dragged on performance, but LabCorp still grew diagnostic sales organically.

By Nick Paul Taylor • April 30, 2019

Labs make their case against PAMA cuts to 3-judge panel

If the U.S. Court of Appeals for the District of Columbia rules in favor of the American Clinical Laboratory Association, ​Quest Diagnostics and LabCorp stand to gain on Wall Street.

By David Lim • April 25, 2019

FDA hits Abaxis with warning letter over changes to assay

The warning letter comes nine months after Zoetis paid $2 billion to acquire Abaxis and its portfolio of veterinary point-of-care diagnostics.

By Nick Paul Taylor • April 25, 2019

Study supports genetic testing for sudden cardiac arrest

The research, published in the Journal of Cardiology, found the tests to be useful regardless of whether patients showed previous clinical evidence of heart disease.  

By Susan Kelly • April 23, 2019

Quest beats analyst Q1 expectations as UnitedHealth drives volume growth

Expanded network access triggered volume growth, but PAMA-related reimbursement pressures sent operating income down 9%.

By Nick Paul Taylor • April 23, 2019

Best Buy, Target jump into at-home device market

The partnership is an example of companies reaching customers through mass retailers, tightening the relationship between healthcare and retail.

By Daphne Howland • April 18, 2019

Abbott beats guidance in Q1, ramps up full-year earnings forecast

The medical device unit led the way once again with 5.5% growth, largely fueled by fast-rising demand for the company's FreeStyle Libre continuous glucose monitor.

By Nick Paul Taylor • April 17, 2019

EU device group clarifies incoming database requirements

The publication of the guidelines comes as Europe races to be ready for the implementation of new medical device regulations.

By Nick Paul Taylor • April 16, 2019

J&J wins FDA OK for first targeted therapy in bladder cancer

The agency also approved a companion diagnostic from Qiagen designed to test alterations in FGFR, which are targeted by first-of-its-kind drug Balversa.

By Ned Pagliarulo • April 12, 2019

LabCorp partners with Qiagen to speed launch of companion diagnostics

The collaboration leverages ​Qiagen's lab program for newly approved cancer drugs and targeted IVDs.

By Meg Bryant • April 5, 2019