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

LabCorp cuts its profit outlook, citing volume shortfall

The announcement follows a profit warning just two days earlier from rival Quest Diagnostics.

By Susan Kelly • Dec. 3, 2018

FDA offers more study options for CLIA waivers in redrafted guidances

The agency added new test design alternatives for manufacturers seeking waivers for IVD devices, a nod to a push from AdvaMed and others.

By Maria Rachal • Nov. 30, 2018

NIST takes early step toward bringing photonic chips into healthcare

The technology opens up new avenues for research by transmitting data via light waves, not electric current.

By Nick Paul Taylor • Nov. 29, 2018

Fighting for market share, LabCorp and Quest plan expansions

The laboratory testing giants are opening new sites on opposite coasts as they pursue market share gains.

By Nick Paul Taylor • Nov. 29, 2018

Quest closes buy of Midwest lab services business

Completion of the deal for Columbia, Missouri-based Boyce and Bynum Pathology Laboratories comes as the lab services giant prepares to release financial results later this week.

By Susan Kelly • Updated Feb. 12, 2019

Metagenomic sequencing shows promise in diagnosing airway infections

The test zeroed in on causative pathogens in lower respiratory tract infections, which are the leading cause of infectious disease-related deaths globally yet have been notoriously challenging to diagnose.

By Nick Paul Taylor • Nov. 28, 2018

Beckman initiates Class I recall of flow cytometers

FDA is concerned inaccurate results provided by the devices could lead to serious injuries or deaths.

By Nick Paul Taylor • Nov. 22, 2018

Millennial to menopausal, women's health is fertile space for startups

Early-stage investors have increased support for female-specific devices and direct-to-consumer diagnostics in the last five years, as the women’s health market is poised to reach $50 billion globally by 2025.

By Maria Rachal • Nov. 14, 2018

3D printing poised to disrupt healthcare

Health industry types are "100% convinced, and rightly so, that [3D printing] will be a core part of their business in five to 10 years," ISG's Michael Harmon said.

By Meg Bryant • Nov. 12, 2018

Quest Diagnostics adds Apple Health integration for lab results

The move follows rival LabCorp's deal with Apple to add a similar integration for iPhone users.

By David Lim • Nov. 12, 2018

FDA clears battery-powered Ebola test for emergency use

The regulatory decision adds to the testing capabilities of public health clinics and treatment centers.

By Nick Paul Taylor • Nov. 12, 2018

LabCorp loses 2019 Horizon BCBSNJ exclusivity as Quest enters the fray

The deal means the two clinical laboratory giants will compete for some of the New Jersey insurer's members.

By Nick Paul Taylor • Nov. 9, 2018

ACLA praises CMS for boosting data collection

The clinical lab trade group lauded the agency for taking steps to increase the number of laboratories submitting data informing Medicare payment rates.

By David Lim • Nov. 5, 2018

FDA warns about Roche test after reports of patient strokes

Two patients suffered serious injuries involving strokes, prompting a warning that inaccurate results from the Swiss pharma's CoaguChek could cause serious injuries or death when taken with the blood thinner warfarin.

By Nick Paul Taylor • Nov. 2, 2018

23andMe wins FDA clearance for first-of-its-kind genetic test

The agency also sent a safety communication warning about the danger of relying on genetic tests that have not been reviewed by FDA making claims about patient response to individual medications.

By David Lim , Nick Paul Taylor • Nov. 1, 2018

LabCorp rolls out Apple Health integration for lab test results

CEO David King argued the move to enable patients to view their testing results comes at a time when individuals are increasingly interested in gaining a "more holistic view of their health."

By David Lim • Oct. 31, 2018

5 sticking points in the EU medical device reg transition

Brexit and notified body capacity are among the uncertainties, as many in the medtech sector are uninformed.

By Meg Bryant • Oct. 29, 2018

Philips launches all-in-one breast ultrasound product

The technology package is designed to make exams easier and faster for patients and physicians.

By Susan Kelly • Oct. 29, 2018

FDA clears Ansh Labs menopausal status test

Physicians can use the results to inform actions to prevent osteoporosis and heart disease.

By Nick Paul Taylor • Oct. 25, 2018

FDA starts 510(k) pilot to cut optical tomography processing times

The program aims to give developers of optical coherence tomography devices the chance to discuss premarket performance testing recommendations with the agency.

By Nick Paul Taylor • Oct. 24, 2018

Quest disappoints with full year revenue forecast cut

The lab giant said its business remains pressured by an industrywide decline in hepatitis C testing. Investors sent shares down 7% in morning trade.

By Susan Kelly • Updated Oct. 23, 2018

Myriad's BRCA test supports successful ovarian cancer trial

The molecular diagnostics company plans to file to expand use of the genetic test.

By Nick Paul Taylor • Oct. 23, 2018