FDA clears NGS test to detect residual blood cancer cells

Adaptive Biotechnologies' assay detects and monitors minimal residual disease in multiple myeloma and B-cell acute lymphoblastic leukemia patients.

By Susan Kelly • Oct. 1, 2018

New IMDRF committee to tackle cybersecurity threats

The FDA device chief laid out takeaways from the group's Beijing meeting.

By Kim Dixon • Sept. 27, 2018

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

Global device industry set to grow 5.6% a year through 2024: report

In vitro diagnostics is projected to remain as the No. 1 specialty in 2024 with annual sales of $79.6 billion and a 13.4% share of the medical device industry.

By Susan Kelly • Sept. 26, 2018

Premier gets FDA clearance for saliva-based opioid tests

The regulatory nod expands use of OralTox to oxycodone and methadone.

By Nick Paul Taylor • Sept. 26, 2018

Medtech companies race to adapt amid vertical integration, new tech threats

The industry is increasingly sharing the risk with payers as a way to prove product value.

By Kim Dixon • Sept. 25, 2018

AdvaMed chief: Success in warding off tariffs, but impact rising

While medical devices aren't explicitly on the most recent list of tariffs, the list likely includes component parts used by members of the industry.

By Kim Dixon • Sept. 25, 2018

ACLA lab payment lawsuit dismissed by judge

The clinical lab lobby had argued HHS did not collect data from a wide enough range of laboratories when establishing Medicare payment rates.

By David Lim • Sept. 24, 2018

Medicare lab test spending up slightly in 2017: OIG

The top five tests — four common blood tests and a test for Vitamin D3 levels — totaled $2.2 billion.

By Susan Kelly • Sept. 21, 2018

US wins kickback case against clinical lab Calloway

Calloway Laboratories is on the hook for $1.3 million for submitting false claims to Medicare and other federal healthcare programs.

By Nick Paul Taylor • Sept. 21, 2018

Thermo Fisher licenses CRISPR tech from Broad Institute

The instruments maker aims to meet the growing demand for contracting services from companies using CRISPR in drug R&D. 

By Suzanne Elvidge • Sept. 19, 2018

MYnd gets breakthrough tag for mental health decision support tool

The technology works by comparing the brain activity of a patient to those of people with similar patterns to zero in on the drugs that have worked in analogous situations in the past. 

By Nick Paul Taylor • Sept. 19, 2018

ACLA, AdvaMedDx urge CMS to delay payment cuts

The clinical lab trade group sued HHS last year over data collection from labs used to set Medicare reimbursement rates.

By David Lim • Sept. 18, 2018

Intermountain, Geisinger form group to improve diagnostic accuracy

The two health systems are among more than 40 organizations calling for providers to take steps like improving how doctors communicate test results.

By Meg Bryant • Sept. 14, 2018

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