Gottlieb: FDA pursuing faster approval path for diagnostics

The agency chief said it should focus its premarket reviews on a subset of higher risk or highly novel tests, companion diagnostics and tests for home use.

By Susan Kelly • Sept. 14, 2018

Companion diagnostic for bile duct cancer treatment in works

Incyte and genomic profiling company Foundation Medicine announced an agreement to develop a companion diagnostic for pemigatinib, Incyte's FGFR1/2/3 inhibitor for patients with cholangiocarcinoma.

By Susan Kelly • Sept. 12, 2018

Becton Dickinson sells bioprocessing business to Thermo Fisher

Divesting the unit will allow Becton to better focus its life sciences division on disease and therapy research and clinical diagnostics.

By Susan Kelly • Sept. 10, 2018

23andMe reportedly exploring premium DNA test service

The company is gauging user interest in a $749 product for a deeper individual DNA profile, but has no immediate plans to launch one, according to CNBC.

By Meg Bryant • Sept. 7, 2018

European Society of Cardiology endorses iFR in guidelines

Royal Philips obtained the technology in its 2015 acquisition of Volcano Corp.

By Susan Kelly • Sept. 4, 2018

NIH awards $3.8M to test fMRI and suicidal thinking

The approach looks at the brain activity linked to certain words to diagnose suicidal thinking.

By Nick Paul Taylor • Aug. 30, 2018

Gottlieb hails early breakthrough device successes, plans AI benchmarks

The commissioner set out how the FDA is accelerating the development of medical devices.

By Nick Paul Taylor • Aug. 30, 2018

IDx publishes AI test data that supported landmark approval

The company sees the diagnostic as a useful tool enabling primary care physicians to screen for diabetic retinopathy.

By Nick Paul Taylor • Aug. 29, 2018

Roche Diagnostics CEO exits after 10 years

Roland Diggelmann will leave the company at the end of September.

By David Lim • Aug. 28, 2018

FDA approves Keytruda companion test for bladder cancer

Measuring levels of PD-L1 expressed in patients' tumors can help doctors determine who is likely to benefit from immunotherapy treatment.

By Susan Kelly • Aug. 22, 2018

Pfizer inks marketing deal for Exact's Cologuard

Exact said about 401,000 tests were performed during the first six months of 2018, leading to revenue of $193 million. The CEO now expects $700 million in sales for next year.

By Andrew Dunn • Aug. 22, 2018

LDT legislation gains allies, moves closer to finish line

At the same time, FDA comments on the bill drew the ire of the clinical lab sector.

By David Lim • Aug. 21, 2018

Early A1C test may reduce gestational diabetes risk: NIH study

The NIH researchers analyzed records from the NICHD Fetal Growth Study of more than 2,000 low-risk pregnant women from 12 U.S. clinical sites between 2009 and 2013.

By Susan Kelly • Aug. 17, 2018

DeepMind's AI detects over 50 eye diseases with 94% accuracy, study shows

The work is a collaboration between Google's DeepMind subsidiary, Moorfields Eye Hospital and University College London to speed diagnosis and referrals for sight-threatening eye diseases.

By Meg Bryant • Aug. 15, 2018

AdvaMed pushes back against FDA humanitarian device guidance

The trade group thinks the guidance will deter development of devices to treat rare conditions.

By Nick Paul Taylor • Aug. 15, 2018

Medical device industry caught in US-China trade war

"If this keeps escalating … a tit-for-tat game without any end in sight, that's very concerning to our industry and ultimately to patient care," a top industry imaging official said.

By Meg Bryant • Aug. 13, 2018

FDA warns overreliance on membrane tests could up fetal death risk

The rupture test results could be misinterpreted, leading to serious adverse events.

By Nick Paul Taylor • Aug. 9, 2018

Boston Children's expands sequencing of patients with epilepsy, IBD

The hospital hopes to learn more about disease pathways and identify novel drug targets.

By Nick Paul Taylor • Aug. 8, 2018

New blood test can rule out heart attack faster

The new test showed greater sensitivity and precision than the fourth-generation conventional test currently in use in the United States.

By Susan Kelly • Aug. 7, 2018

UK regulators reassure medtech sector about Brexit impact

The MHRA expects little to change until 2021 but the risk of significant near-term upheaval remains.

By Nick Paul Taylor • Aug. 7, 2018

Industry urges Congress to ease clinical lab pay cuts

The medical device and hospital industries are among those arguing that under the first six months of new reimbursement rates, labs have cut staff, resulting in limited or ended home care visits for homebound patients.

By David Lim • Aug. 3, 2018

Bio-Techne closes $250M Exosome Diagnostics takeover

The acquisition moves the company into the nascent liquid biopsy sector.

By Nick Paul Taylor • Aug. 3, 2018

Siemens Healthineers hits Q3 goals as imaging sales rise

Demand for molecular imaging, X-ray products and magnetic resonance drove growth.

By Nick Paul Taylor • Aug. 2, 2018

MedTech Europe seeks 'urgent' changes to EU regs deadlines

The trade group proposes either stopping the clock on the countdown to the end of the transition periods or delaying the implementation dates for all products, or just legacy products. 

By Nick Paul Taylor • July 31, 2018

ECRI safety panel advises 3 ways to avoid diagnostic testing, medicine mix-ups

"The problem of not closing the loop has a significant impact on patients and caregivers, and can lead to devastating effects on the outcome of patients, workgroup chair Chris Lehmann said.

By David Lim • July 27, 2018