Ascension hospital network taps Abbott diagnostics for lab work

The deal will put Abbott's Alinity diagnostic systems to work for an additional 2.4 million patients.

By Susan Kelly • March 6, 2019

Machine learning model aims to match pathologists in IDing lung cancer

In an early test, a recently developed neural network proved to be "statistically on par" with the expertise of three pathologists in classifying lung cancer slides.

By Nick Paul Taylor • March 5, 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

Blood test identifies proteins to predict preterm birth

Researchers found that five circulating microparticle proteins in first trimester blood samples could help predict risk, including among first-time mothers.

By Susan Kelly • March 4, 2019

Liquid biopsy as effective as tissue biopsy in lung cancer, study finds

A clinical trial found Guardant Health's test detected advanced non-small cell lung cancer at a similar rate to traditional tissue-based biopsies.

By Emily Mullin • March 1, 2019

Gene test for antibiotic resistance gets FDA breakthrough nod

The World Health Organization has identified antibiotic resistance as one of the biggest threats to global health.

By Susan Kelly • March 1, 2019

Thermo Fisher lung cancer test wins expanded approval in Japan

Japan's regulatory agency approved the Oncomine DX Target test to include three additional biomarkers for non-small cell lung cancer.  

By Susan Kelly • Feb. 27, 2019

Feds team up to speed diagnostic testing access in emergencies

Labs using an in vitro diagnostic granted an Emergency Use Authorization must still comply with Clinical Laboratory Improvement Amendments regulations.  

By David Lim • Feb. 27, 2019

Myriad plans companion diagnostic filing as PARP drug clears clinical test

The company said Thursday its BRACAnalysis CDx diagnostic will be used to find germline BRCA mutations in men with certain prostate cancers in a Phase 3 study.

By Nick Paul Taylor • Updated April 4, 2019

Verily launches eye disease screening algorithm in India

The company also said the algorithm won CE mark approval, but did not reveal its plans for the technology in Europe.

By Susan Kelly • Feb. 26, 2019

FDA warns breast infrared imaging tool should not replace mammography

Total Thermal Imaging's thermography system has not been cleared as a standalone diagnostic tool, and the technology lacks scientific evidence to support its use in breast cancer screening, the agency said.

By Susan Kelly • Feb. 26, 2019

Philips' camera-guided digital imaging system gets FDA OK

The nod comes after Philips reported fourth quarter growth in image-guided therapy, ultrasound and diagnostic imaging.

By Meg Bryant • Feb. 21, 2019

Intuitive gains FDA clearance for Ion lung catheter

The robot-assisted surgery pioneer said it plans a measured U.S. rollout of the system with customer shipments beginning in the second quarter.

By Susan Kelly • Feb. 20, 2019

ACLA, AdvaMedDx clash on lab test overhaul bill

The latest version of draft legislation incorporated suggestions from FDA, including a precertification program. The Pew Charitable Trusts cautioned that may open up patients to risk from unreviewed products.

By David Lim • Feb. 20, 2019

FDA grants breakthrough status to concussion-detecting VR headset

The SyncThink device analyzes the wearer's eye movements. The medtech has deals with the Golden State Warriors and hospitals including Mass General.

By Nick Paul Taylor • Feb. 20, 2019

FDA grants breakthrough status to amyloid beta Alzheimer's test

The assay analyzes the ratio of two forms of amyloid beta in cerebrospinal fluid to help determine if a patient has Alzheimer's.

By Nick Paul Taylor • Feb. 15, 2019

Headwinds stiffen as Quest revenues, earnings miss Q4 estimates

Elements of the fourth quarter financial results align with performance of chief rival LabCorp. Both companies are contending with Medicare rate reductions as a result of PAMA.

By Nick Paul Taylor • Feb. 14, 2019

Software products face high-risk upclassing in Australia

The Therapeutic Goods Administration wants to significantly increase the regulatory burden on medical software, with some products potentially jumping from the lowest to highest risk category.

By Nick Paul Taylor • Feb. 14, 2019

GenomeDx pays $2M to settle genetic test false claims allegations

The U.S. government accused the company of billing Medicare for unnecessary prostate cancer tests.

By Nick Paul Taylor • Feb. 13, 2019

Industry strikes back at GAO's 'flawed and dangerous' PAMA report

AdvaMedDx and the other trade groups want to meet with the watchdog to discuss the dispute over the contention the payment law would cost Medicare billions rather than save.

By Nick Paul Taylor • Feb. 13, 2019

Rapid test for brain injury gets FDA breakthrough status

The test measures protein biomarkers released from the brain into the bloodstream after a head trauma, producing results in as little as 90 seconds.

By Susan Kelly • Feb. 12, 2019

LabCorp diagnostics' operating income tumbles as PAMA hits home

Reimbursement changes wiped $18 million off LabCorp's adjusted operating income, contributing to a 22% drop at the diagnostics unit.

By Nick Paul Taylor • Feb. 7, 2019

FDA categorizes Edwards' cardiac diagnostic recall as Class I event

Edwards pulled the catheters from the market after learning that an assembly error was causing the devices to display inaccurate information.

By Nick Paul Taylor • Feb. 7, 2019

Cognoa's autism devices win breakthrough status

The special FDA designation covers the company's digital devices designed to improve the diagnosis and treatment of autism.

By Nick Paul Taylor • Feb. 6, 2019

Healthcare groups urge CMS to keep coverage of NGS cancer tests

Sixty-three healthcare companies and organizations argued the agency's approach to covering next generation sequencing will restrict cancer patients' access to essential tests.

By Susan Kelly • Feb. 5, 2019

Oxipit AI-based tool for chest X-ray analysis gets CE mark

The Lithuania-based startup is betting the system can help radiologists increase productivity, detect hard-to-catch pathologies, decrease error rates and serve as a second opinion.

By Susan Kelly • Feb. 4, 2019